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

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 the device name listed in this FDA 510(k) record. The listed applicant is Careplus (M) Sdn Bhd. It received FDA 510(k) clearance on 2021-08-20 under 510(k) 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. The listed applicant is Careplus (M) Sdn Bhd. The 510(k) number is K203705.

When did Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) receive FDA 510(k) clearance?

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 510(k) number K203705.

Who is the listed applicant for Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)?

The FDA 510(k) record lists Careplus (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

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 records listing Careplus (M) Sdn Bhd as applicant

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 K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST

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Related Devices (Code: LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

Official Source

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