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FDA 510(k)

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White

K-Number: K212482 · 2022-08-09

ApplicantSri Trang Gloves (Thailand) Public Company Limited
Decision Date2022-08-09
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is a medical device manufactured by Sri Trang Gloves (Thailand) Public Company Limited. It received FDA 510(k) clearance on 2022-08-09 under approval number K212482. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White?

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is a medical device that received FDA 510(k) clearance on 2022-08-09. It is manufactured by Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K212482.

When was Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White approved by the FDA?

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White received FDA 510(k) clearance on 2022-08-09, under approval number K212482.

What company makes Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White?

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is manufactured by Sri Trang Gloves (Thailand) Public Company Limited.

What is the FDA product code for Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White?

The FDA product code for Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is LYY.

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Other Devices by Sri Trang Gloves (Thailand) Public Company Limited

K200539Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl K193581Non-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 K221165Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl K212309Non-sterile, Powder-Free Latex Examination Glove K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White) K232614Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)

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Related Devices (Code: LYY)

K162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or lessVietglove Corporation K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveHartalega Sdn Bhd K153744A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)A1 Glove Sdn Bhd K152593LATEX EXAMINATION GLOVE POWDER FREECareplus (M) Sdn Bhd K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATEDVietglove Corporation K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable proteinTerang Nusa Sdn Bhd

Official Source

View on FDA Database →

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