FDA 510(k)

SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

K-Number: K013821 · 2002-03-05

Decision Date2002-03-05

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Top Quality Mfg., Inc.. It received FDA 510(k) clearance on 2002-03-05 under 510(k) number K013821. 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 SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)?

SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) is a medical device that received FDA 510(k) clearance on 2002-03-05. The listed applicant is Top Quality Mfg., Inc.. The 510(k) number is K013821.

When did SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) receive FDA 510(k) clearance?

SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) received FDA 510(k) clearance on 2002-03-05, under 510(k) number K013821.

Who is the listed applicant for SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)?

The FDA 510(k) record lists Top Quality Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)?

The FDA product code for SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) is LYY.

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Other records listing Top Quality Mfg., Inc. as applicant

K013254POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)K004018SKINGARD POLYCOAT GLOVE K000050TOP QUALITY CHLORINATED-POWDERFREE 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.