medical gloves fda 510k guidance

High Elasticity:
Stretch Resistance

Thick Design:
Puncture Resistant

Sealed &Waterproof:
Care for Your Hands

Latex and allergy free:

These gloves have latex free materials that are useful for those people who have allergy to the latex. 

Puncture resistant:

Nitrile gloves are specifically manufactured in a puncture-proof technology. 

Full-proof sensitivity:

These are produced to fulfill sensitivity requirements.

FDA Update: Enforcement Policies for Gowns, Gloves ...- medical gloves fda 510k guidance ,Apr 09, 2020·Gowns, gloves and other apparel that are intended for medical purposes are FDA-regulated medical devices (e.g., those regulated under 21 CFR §§ 878.4040, 880.6250 and 878.4460). FDA will consider factors such as labeling and promotional claims, intended users and modifications ( e.g ., anti-microbial agents), to determine whether these ...FDA 510(K) Submission | 510K Clearance (Approval) | FDA ...FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.



FDA 510(k) Applications for Medical Device Product Code ...

FDA 510(k) Number: Applicant: Device Name: Decision Date: K841676: ABCO DEALERS, INC. DISPOSABLE POLY GLOVES: 05/22/1984: K972195: ABSOLUTE SYNTHETIC TECHNOLOGIES ...

Halyard Health Christine Macauley Regulatory Affairs ...

510(k) Summary (K180646) Page 2 of 5 Indications for Use The Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and

FDA finalizes speedier medical device pathway alternative ...

Jan 06, 2021·Dive Brief: FDA Tuesday published final guidance on its n ew Safer Technologies Program for Medical Devices (STeP) program, targeted at products with significant safety benefits in non-life-threatening or reasonably reversible conditions less serious than those eligible for the agency's Breakthrough Devices Program.. The guidance for its voluntary STeP program is intended to provide …

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ...

510(k) SUMMARY WRP Summary, Section D, K141982, Page 2 of 5 5.0 Intended Use of the Device: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Halyard Health Christine Macauley Regulatory Affairs ...

510(k) Summary (K180646) Page 2 of 5 Indications for Use The Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and

US FDA 510k and Registration for Gloves - I3CGLOBAL

Sep 21, 2020·510(k) Remarks . Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of ...

FDA 510(k) Applications for Medical Device: Vinyl Patient ...

fda 510(k) number applicant address city / country state / province postal code; k103772: advanced medical devices factory: no. 8-1 xing'an road: weifang, shandong: 262600: k130732: aide plastic co., ltd. rm 1606 bldg.1, jianxiang yuan no.209 bei si huan zhong rd. beijing: 100083: k130890: air plastic co., ltd. room 1606 bldg. 1 jianxiang yuan ...

Section 6 510(k) Summary 510(K) Summary

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process. 9.0 Substantial Equivalence Comparison: Features & Predicate Device Medical Glove Subject Device Result of Description __ ____ Guidance Manual _____Cornarison …

Regulations of Personal Protective Equipment (PPE) in ...

Apr 28, 2020·gloves during the pandemic. FDA suggests using medical gloves beyond shelf-life during crises where risk of transmission is low. During extended use of medical gloves between patients with no known infectious diseases, gloved hands should be cleaned between patients. Alcohol-based hand sanitizers may degrade vinyl gloves. If a glove becomes ...

Importing Medical Gloves to the USA: Info & Regulations ...

Jun 15, 2020·The FDA does not intend to object to the distribution and use of surgeon’s gloves that do not comply with the following regulatory requirements where the surgeon’s gloves do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,31 ...

FDA Updates Medical Glove Recommendations

Feb 15, 2008·The FDA has updated its recommendations for makers of medical gloves in a guidance covering testing, importation and 510(k) submissions. Gloves used for biocompatibility studies must contain the same colorants, fragrances, flavors, powders, lubricants and processing chemicals as finished products, the guidance says.

510(k) Premarket Notification

Jan 18, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K193581: Device Name: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster

What Medical Device and Gown Importers Need to Know ...

2. FDA did not revoke its March 2020 Enforcement Discretion Guidance and so it is still in effect for the devices it covers (including gowns and patient exam and surgical gloves that would ordinarily require a 510(k), but lack that FDA clearance — subject to the conditions of that Guidance Document).

Importing Medical Gloves to the USA: Info & Regulations ...

Jun 15, 2020·The FDA does not intend to object to the distribution and use of surgeon’s gloves that do not comply with the following regulatory requirements where the surgeon’s gloves do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,31 ...

SUMMARY OF FDA GUIDANCE FOR GOWNS AND OTHER …

Apr 08, 2020·FDA guidance is provided in the March 30, 2020 Guidance Document re: Enforcement Policy for Gowns, Other Apparel, and Gloves During the COVID-19 Public Health Emergency, FDA-2020-D-1138, which is available at:

Tests required for latex and nitrile gloves for FDA 510K ...

FDA Classification for examination and surgical gloves. US FDA Medical Device Labeling Requirements - Gloves. Contents of examination and surgical gloves (Latex / Nitrile) 510k Notification. US FDA 510K Submission Format. FDA publish all 510k clearance on fda website, you can find substantial equivalence letter at www.fda.gov. Below are ...

FDA Registration of Latex and Nitrile gloves - fdahelp.us

FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration and device listing to market in the USA.Powdered gloves are not allowed to market in the USA for medical purpose.

Medical Gloves for COVID-19 | FDA

A: To identify FDA-cleared medical gloves, search the 510(k) Premarket Notification database using the product codes for medical gloves listed in the previous Q&A. Shortages of Medical Gloves ...

What Medical Device and Gown Importers Need to Know ...

2. FDA did not revoke its March 2020 Enforcement Discretion Guidance and so it is still in effect for the devices it covers (including gowns and patient exam and surgical gloves that would ordinarily require a 510(k), but lack that FDA clearance — subject to the conditions of that Guidance Document).

FDA Relaxes Enforcement Policies for Medical Gowns and Gloves

Update 06/04/2020. In March 2020, FDA issued a guidance document announcing an enforcement discretion policy for gowns, drapes, gloves, etc. Under this guidance document, FDA granted enforcement discretion from the ordinary regulatory requirements for these medical devices.

FDA 510(k) Applications for Medical Device: Vinyl Patient ...

fda 510(k) number applicant address city / country state / province postal code; k103772: advanced medical devices factory: no. 8-1 xing'an road: weifang, shandong: 262600: k130732: aide plastic co., ltd. rm 1606 bldg.1, jianxiang yuan no.209 bei si huan zhong rd. beijing: 100083: k130890: air plastic co., ltd. room 1606 bldg. 1 jianxiang yuan ...

FDA 510(k) Applications for Medical Device: Surgeon'S Gloves

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code; K893834: ACCURATE MEDICAL DEVICES, INC. 7522 B SLATER AVE., #112: HUNTINGTON BEACH

New FDA Guidance for Surgical Apparel Due to COVID-19 ...

Apr 03, 2020·The Food and Drug Administration (FDA) recently published a new guidance document to help expand the availability of surgical apparel, including gowns, hoods, and surgical & patient examination gloves, in response to the COVID-19 public health emergency.

FDA 510k Fees For Medical Device - 🥇I3CGLOBAL

The main reason was the pricing and additional billing for closing/answering FDA queries. The majority of them spent $30,000 – $50,000 with other consulting companies only for guidance and review. Check out our pricing estimate of FDA 510(k) fee for each activity till you get the clearance. We will not ditch you halfway! Contact us today.