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FDA 510(k)

POWDER FREE SURGEON'S GLOVE

K-Number: K944054 · 1994-11-17

ApplicantArent Fox
Decision Date1994-11-17
Product CodeKGD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

POWDER FREE SURGEON'S GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Arent Fox. It received FDA 510(k) clearance on 1994-11-17 under 510(k) number K944054. The device is classified under product code KGD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDER FREE SURGEON'S GLOVE?

POWDER FREE SURGEON'S GLOVE is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Arent Fox. The 510(k) number is K944054.

When did POWDER FREE SURGEON'S GLOVE receive FDA 510(k) clearance?

POWDER FREE SURGEON'S GLOVE received FDA 510(k) clearance on 1994-11-17, under 510(k) number K944054.

Who is the listed applicant for POWDER FREE SURGEON'S GLOVE?

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

What is the FDA product code for POWDER FREE SURGEON'S GLOVE?

The FDA product code for POWDER FREE SURGEON'S GLOVE is KGD.

Related Clinical Trials

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Other records listing Arent Fox 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.

K945843SAFETY PLUSK944053NATURAL RUBBER LATEX SURGEONS GLOVEK945583OCUSYSTEM(ART)

Related Devices (Code: KGD)

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.

K891902CHISELS- FREER, LUCAS, ALEXANDER, BISHOPZinnanti Surgical Instruments, 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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