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FDA 510(k)

NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC

K-Number: K991849 · 1999-07-07

ApplicantSeal Polymer Industries Bhd.
Decision Date1999-07-07
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC is the device name listed in this FDA 510(k) record. The listed applicant is Seal Polymer Industries Bhd.. It received FDA 510(k) clearance on 1999-07-07 under 510(k) number K991849. 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 NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC?

NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC is a medical device that received FDA 510(k) clearance on 1999-07-07. The listed applicant is Seal Polymer Industries Bhd.. The 510(k) number is K991849.

When did NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC receive FDA 510(k) clearance?

NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC received FDA 510(k) clearance on 1999-07-07, under 510(k) number K991849.

Who is the listed applicant for NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC?

The FDA 510(k) record lists Seal Polymer Industries Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC?

The FDA product code for NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC is LYY.

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Other records listing Seal Polymer Industries 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.

K042238CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVESK042101CASHMERE POWDER FREE NITRILE EXAMINATION GLOVESK032077CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)K022792CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED)K021388CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAMK020868CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)

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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

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

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