FDA 510(k)

POWDER FREE CHLORINATED GLOVES-(TEXTURED)

K-Number: K981164 · 1998-04-23

ApplicantPan-Century Rubber Products Sdn. Bhd.

Decision Date1998-04-23

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER FREE CHLORINATED GLOVES-(TEXTURED) is the device name listed in this FDA 510(k) record. The listed applicant is Pan-Century Rubber Products Sdn. Bhd.. It received FDA 510(k) clearance on 1998-04-23 under 510(k) number K981164. 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 CHLORINATED GLOVES-(TEXTURED)?

POWDER FREE CHLORINATED GLOVES-(TEXTURED) is a medical device that received FDA 510(k) clearance on 1998-04-23. The listed applicant is Pan-Century Rubber Products Sdn. Bhd.. The 510(k) number is K981164.

When did POWDER FREE CHLORINATED GLOVES-(TEXTURED) receive FDA 510(k) clearance?

POWDER FREE CHLORINATED GLOVES-(TEXTURED) received FDA 510(k) clearance on 1998-04-23, under 510(k) number K981164.

Who is the listed applicant for POWDER FREE CHLORINATED GLOVES-(TEXTURED)?

The FDA 510(k) record lists Pan-Century Rubber Products Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE CHLORINATED GLOVES-(TEXTURED)?

The FDA product code for POWDER FREE CHLORINATED GLOVES-(TEXTURED) is LYY.

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Other records listing Pan-Century Rubber Products Sdn. Bhd. as applicant

K993183POWDER FREE GLOVES (POLYMER COATED)K993287POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM K955241HIGH RISK GLOVES K924633HYPOALLERGENIC LATEX GLOVES K910047PATIENT EXAMINATION GLOVES-TEXTURED GLOVES K910045PATIENT EXAMINATION GLOVES-POWDER FREED

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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.