Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STERILE SURGICAL DRAPES

K-Number: K821666 · 1982-06-21

ApplicantPhoenix Glove Co.
Decision Date1982-06-21
Product CodeFJZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERILE SURGICAL DRAPES 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 1982-06-21 under 510(k) number K821666. The device is classified under product code FJZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE SURGICAL DRAPES?

STERILE SURGICAL DRAPES is a medical device that received FDA 510(k) clearance on 1982-06-21. The listed applicant is Phoenix Glove Co.. The 510(k) number is K821666.

When did STERILE SURGICAL DRAPES receive FDA 510(k) clearance?

STERILE SURGICAL DRAPES received FDA 510(k) clearance on 1982-06-21, under 510(k) number K821666.

Who is the listed applicant for STERILE SURGICAL DRAPES?

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 SURGICAL DRAPES?

The FDA product code for STERILE SURGICAL DRAPES is FJZ.

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-STERILEK821043STERILE PATIENT EXAM. GLOVESK801846ELECTROCARDIOGRAPH ELECTRODEK781820GLOVES, VINYL EXAMINATION

Related Devices (Code: FJZ)

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.

K821313SURGICAL UTILITY DRAPEMegaplast, Inc.K760995DECOLLATING TRAYDravon Medical, 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.

↑