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510(k) K211620

Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) by Shen Wei USA, Inc. — Product Code LYY

K211620 is an FDA 510(k) premarket notification submitted by Shen Wei USA, Inc. for the device "Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)". The FDA issued a decision of Substantially Equivalent on August 19, 2021. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Shen Wei USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2021
Date Received
May 26, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Latex Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Other clearances by Shen Wei USA, Inc.

  • K213141 — Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low (May 28, 2022)
  • K213142 — Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray (January 28, 2022)
  • K213144 — Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors (December 22, 2021)
  • K211455 — Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White C (July 28, 2021)
  • K202085 — Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential C (June 21, 2021)
  • K202083 — Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low D (March 25, 2021)
  • K202080 — Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential (March 24, 2021)
  • K202081 — Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Poten (March 19, 2021)
  • K202082 — Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-Whit (March 17, 2021)
  • K202086 — Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Cl (March 16, 2021)

Other clearances for product code LYY

  • K250069 — Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Prot (April 29, 2025)
  • K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) (September 9, 2024)
  • K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Pr (June 13, 2023)
  • K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (February 22, 2023)
  • K222612 — Powder-Free Latex examination gloves (November 25, 2022)
  • K221667 — Non Sterile Powder Free Latex Examination Glove (October 28, 2022)
  • K222348 — JR MEDIC (October 27, 2022)
  • K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (October 26, 2022)
  • K222693 — Single-use medical latex examination gloves (LG100) (September 24, 2022)
  • K221648 — Iconic Latex Glove (August 25, 2022)

FDA data resources