FDA 510(k)

RUBBERCARE PATIENT EXAMINATION GLOVE

K-Number: K891123 · 1989-07-14

ApplicantPerusahaan Pelindung Getah (M) Sdn Bhd

Decision Date1989-07-14

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

RUBBERCARE PATIENT EXAMINATION GLOVE 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 1989-07-14 under 510(k) number K891123. 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 PATIENT EXAMINATION GLOVE?

RUBBERCARE PATIENT EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Perusahaan Pelindung Getah (M) Sdn Bhd. The 510(k) number is K891123.

When did RUBBERCARE PATIENT EXAMINATION GLOVE receive FDA 510(k) clearance?

RUBBERCARE PATIENT EXAMINATION GLOVE received FDA 510(k) clearance on 1989-07-14, under 510(k) number K891123.

Who is the listed applicant for RUBBERCARE PATIENT EXAMINATION GLOVE?

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 PATIENT EXAMINATION GLOVE?

The FDA product code for RUBBERCARE PATIENT EXAMINATION GLOVE is LYY.

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Other records listing Perusahaan Pelindung Getah (M) Sdn Bhd as applicant

K072300POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM K032201RUBBERCARE POWDERED LATEX EXAMINATION GLOVES K002111RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI K002112RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE K002114RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER K994201RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

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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.