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FDA 510(k)

HIGH RISK GLOVES

K-Number: K955241 · 1996-05-28

ApplicantPan-Century Rubber Products Sdn. Bhd.
Decision Date1996-05-28
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HIGH RISK GLOVES 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 1996-05-28 under 510(k) number K955241. 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 HIGH RISK GLOVES?

HIGH RISK GLOVES is a medical device that received FDA 510(k) clearance on 1996-05-28. The listed applicant is Pan-Century Rubber Products Sdn. Bhd.. The 510(k) number is K955241.

When did HIGH RISK GLOVES receive FDA 510(k) clearance?

HIGH RISK GLOVES received FDA 510(k) clearance on 1996-05-28, under 510(k) number K955241.

Who is the listed applicant for HIGH RISK GLOVES?

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 HIGH RISK GLOVES?

The FDA product code for HIGH RISK GLOVES is LYY.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K993183POWDER FREE GLOVES (POLYMER COATED)K993287POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMK981164POWDER FREE CHLORINATED GLOVES-(TEXTURED)K924633HYPOALLERGENIC LATEX GLOVESK910047PATIENT EXAMINATION GLOVES-TEXTURED GLOVESK910045PATIENT EXAMINATION GLOVES-POWDER FREED

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Related Devices (Code: LYY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 LimitedK230573Powder 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 BhdK223298Sterile 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

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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