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FDA 510(k)

NITRILE RUBBER EXAMINATION GLOVES (POWERED)

K-Number: K932405 · 1994-05-18

ApplicantSafeskin Corp.
Decision Date1994-05-18
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NITRILE RUBBER EXAMINATION GLOVES (POWERED) is the device name listed in this FDA 510(k) record. The listed applicant is Safeskin Corp.. It received FDA 510(k) clearance on 1994-05-18 under 510(k) number K932405. 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 NITRILE RUBBER EXAMINATION GLOVES (POWERED)?

NITRILE RUBBER EXAMINATION GLOVES (POWERED) is a medical device that received FDA 510(k) clearance on 1994-05-18. The listed applicant is Safeskin Corp.. The 510(k) number is K932405.

When did NITRILE RUBBER EXAMINATION GLOVES (POWERED) receive FDA 510(k) clearance?

NITRILE RUBBER EXAMINATION GLOVES (POWERED) received FDA 510(k) clearance on 1994-05-18, under 510(k) number K932405.

Who is the listed applicant for NITRILE RUBBER EXAMINATION GLOVES (POWERED)?

The FDA 510(k) record lists Safeskin Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILE RUBBER EXAMINATION GLOVES (POWERED)?

The FDA product code for NITRILE RUBBER EXAMINATION GLOVES (POWERED) is FMC.

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Other records listing Safeskin Corp. 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.

K993117SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AGK994081SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVESK992830SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVEK992210SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVESK992162SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIMK992062SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES

View all 24 devices →

Related Devices (Code: FMC)

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.

K042618LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)La Glove (M) Sdn. Bhd.K014134POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)Supergrade Healthcare Products Sdn. Bhd.K992337BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTAMexpo Intl., Inc.K932404NITRILE RUBBER POWDER-FREE EXAMINATION GLOVESafeskin Corp.K923175SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.K920649COMPASEPWilde-USA, Inc.

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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