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FDA 510(k)

Powder Free Latex Examination Glove, Non-Sterile

K-Number: K211601 · 2022-08-22

ApplicantWrp Asia Pacific Sdn. Bhd.
Decision Date2022-08-22
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Latex Examination Glove, Non-Sterile is a medical device manufactured by Wrp Asia Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 2022-08-22 under approval number K211601. 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 Powder Free Latex Examination Glove, Non-Sterile?

Powder Free Latex Examination Glove, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-08-22. It is manufactured by Wrp Asia Pacific Sdn. Bhd.. The 510(k) number is K211601.

When was Powder Free Latex Examination Glove, Non-Sterile approved by the FDA?

Powder Free Latex Examination Glove, Non-Sterile received FDA 510(k) clearance on 2022-08-22, under approval number K211601.

What company makes Powder Free Latex Examination Glove, Non-Sterile?

Powder Free Latex Examination Glove, Non-Sterile is manufactured by Wrp Asia Pacific Sdn. Bhd..

What is the FDA product code for Powder Free Latex Examination Glove, Non-Sterile?

The FDA product code for Powder Free Latex Examination Glove, Non-Sterile is LYY.

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Other Devices by Wrp Asia Pacific Sdn. Bhd.

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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 →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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