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FDA 510(k)

STERILE PATIENT EXAM. GLOVES

K-Number: K821043 · 1982-05-21

ApplicantPhoenix Glove Co.
Decision Date1982-05-21
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE PATIENT EXAM. GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Glove Co.. It received FDA 510(k) clearance on 1982-05-21 under 510(k) number K821043. 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 STERILE PATIENT EXAM. GLOVES?

STERILE PATIENT EXAM. GLOVES is a medical device that received FDA 510(k) clearance on 1982-05-21. The listed applicant is Phoenix Glove Co.. The 510(k) number is K821043.

When did STERILE PATIENT EXAM. GLOVES receive FDA 510(k) clearance?

STERILE PATIENT EXAM. GLOVES received FDA 510(k) clearance on 1982-05-21, under 510(k) number K821043.

Who is the listed applicant for STERILE PATIENT EXAM. GLOVES?

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

What is the FDA product code for STERILE PATIENT EXAM. GLOVES?

The FDA product code for STERILE PATIENT EXAM. GLOVES 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Phoenix Glove Co. 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.

K830660STERILE SURGICAL DRAPESK821044PATIENT PREP KITS/TRAYS-STERILEK821666STERILE SURGICAL DRAPESK801846ELECTROCARDIOGRAPH ELECTRODEK781820GLOVES, VINYL EXAMINATION

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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