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FDA 510(k)

RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER

K-Number: K002114 · 2000-08-11

ApplicantPerusahaan Pelindung Getah (M) Sdn Bhd
Decision Date2000-08-11
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER is the device name listed in this FDA 510(k) record. The listed applicant is Perusahaan Pelindung Getah (M) Sdn Bhd. It received FDA 510(k) clearance on 2000-08-11 under 510(k) number K002114. 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 RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER?

RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER is a medical device that received FDA 510(k) clearance on 2000-08-11. The listed applicant is Perusahaan Pelindung Getah (M) Sdn Bhd. The 510(k) number is K002114.

When did RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER receive FDA 510(k) clearance?

RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER received FDA 510(k) clearance on 2000-08-11, under 510(k) number K002114.

Who is the listed applicant for RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER?

The FDA 510(k) record lists Perusahaan Pelindung Getah (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER?

The FDA product code for RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER is LYY.

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Other records listing Perusahaan Pelindung Getah (M) 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.

K072300POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIMK032201RUBBERCARE POWDERED LATEX EXAMINATION GLOVESK002111RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAIK002112RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREEK994201RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)K933759RUBBERCARE LOPRO PATIENT EXAMINATION GLOVES, POWDERED

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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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