FDA 510(k)

POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE

K-Number: K022016 · 2002-10-15

ApplicantTop Glove Medical (Thailand) Co., Ltd.

Decision Date2002-10-15

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Top Glove Medical (Thailand) Co., Ltd.. It received FDA 510(k) clearance on 2002-10-15 under 510(k) number K022016. 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 POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE?

POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2002-10-15. The listed applicant is Top Glove Medical (Thailand) Co., Ltd.. The 510(k) number is K022016.

When did POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE receive FDA 510(k) clearance?

POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 2002-10-15, under 510(k) number K022016.

Who is the listed applicant for POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE?

The FDA 510(k) record lists Top Glove Medical (Thailand) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE?

The FDA product code for POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE is LYY.

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Other records listing Top Glove Medical (Thailand) Co., Ltd. as applicant

K222129Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim K021950TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES

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.