FDA 510(k)

POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)

Q: Who is the listed applicant for POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)?

The FDA 510(k) record lists Supergrade Healthcare Products Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

Q: What is the FDA product code for POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)?

The FDA product code for POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) is FMC.

K-Number: K014134 · 2002-01-22

ApplicantSupergrade Healthcare Products Sdn. Bhd.

Decision Date2002-01-22

Product CodeFMC

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) is the device name listed in this FDA 510(k) record. The listed applicant is Supergrade Healthcare Products Sdn. Bhd.. It received FDA 510(k) clearance on 2002-01-22 under 510(k) number K014134. The device is classified under product code FMC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)?

POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) is a medical device that received FDA 510(k) clearance on 2002-01-22. The listed applicant is Supergrade Healthcare Products Sdn. Bhd.. The 510(k) number is K014134.

When did POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) receive FDA 510(k) clearance?

POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) received FDA 510(k) clearance on 2002-01-22, under 510(k) number K014134.

Who is the listed applicant for POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)?

The FDA 510(k) record lists Supergrade Healthcare Products Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)?

The FDA product code for POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) is FMC.

Related Clinical Trials

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.

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Other records listing Supergrade Healthcare Products Sdn. Bhd. as applicant

K934133PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES)K891232PATIENT EXAMINATION GLOVES

Related Devices (Code: FMC)

K042618LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)La Glove (M) Sdn. Bhd.K992337BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTAMexpo Intl., Inc.K932405NITRILE RUBBER EXAMINATION GLOVES (POWERED)Safeskin Corp.K932404NITRILE RUBBER POWDER-FREE EXAMINATION GLOVESafeskin Corp.K923175SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.K920649COMPASEPWilde-USA, Inc.

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.