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FDA 510(k)

Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)

K-Number: K203705 · 2021-08-20

ApplicantCareplus (M) Sdn Bhd
Decision Date2021-08-20
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) is a medical device manufactured by Careplus (M) Sdn Bhd. It received FDA 510(k) clearance on 2021-08-20 under approval number K203705. 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 Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)?

Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Careplus (M) Sdn Bhd. The 510(k) number is K203705.

When was Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) approved by the FDA?

Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) received FDA 510(k) clearance on 2021-08-20, under approval number K203705.

What company makes Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)?

Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) is manufactured by Careplus (M) Sdn Bhd.

What is the FDA product code for Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)?

The FDA product code for Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) is LYY.

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Other Devices by Careplus (M) Sdn Bhd

K152593LATEX EXAMINATION GLOVE POWDER FREE K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) K201857Powder Free Nitrile Examination Glove Black and Dual Color White-Blue K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs

View all 8 devices →

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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