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FDA 510(k)

ORTHOPEDIC SURGICAL GLOVE

K-Number: K831564 · 1983-07-12

ApplicantAnsell, Inc.
Decision Date1983-07-12
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC SURGICAL GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Ansell, Inc.. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831564. 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 ORTHOPEDIC SURGICAL GLOVE?

ORTHOPEDIC SURGICAL GLOVE is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Ansell, Inc.. The 510(k) number is K831564.

When did ORTHOPEDIC SURGICAL GLOVE receive FDA 510(k) clearance?

ORTHOPEDIC SURGICAL GLOVE received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831564.

Who is the listed applicant for ORTHOPEDIC SURGICAL GLOVE?

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

What is the FDA product code for ORTHOPEDIC SURGICAL GLOVE?

The FDA product code for ORTHOPEDIC SURGICAL GLOVE is FMC.

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Other records listing Ansell, Inc. 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.

K984392ANSELL CONDOMSK983518LIFESTYLES XTRA PLEASUREK940047SPERMICIDALLY LUBRICATED CONDOMK953379HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVEK945766HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVESK945767POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES

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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.K932405NITRILE RUBBER EXAMINATION GLOVES (POWERED)Safeskin Corp.K923175SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., 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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