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)

VARIOUS DISPOSABLE SURGICAL GARMENTS

K-Number: K895235 · 1989-09-19

ApplicantProtect Corp. of Indiana, Inc.
Decision Date1989-09-19
Product CodeFYE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VARIOUS DISPOSABLE SURGICAL GARMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Protect Corp. of Indiana, Inc.. It received FDA 510(k) clearance on 1989-09-19 under 510(k) number K895235. The device is classified under product code FYE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIOUS DISPOSABLE SURGICAL GARMENTS?

VARIOUS DISPOSABLE SURGICAL GARMENTS is a medical device that received FDA 510(k) clearance on 1989-09-19. The listed applicant is Protect Corp. of Indiana, Inc.. The 510(k) number is K895235.

When did VARIOUS DISPOSABLE SURGICAL GARMENTS receive FDA 510(k) clearance?

VARIOUS DISPOSABLE SURGICAL GARMENTS received FDA 510(k) clearance on 1989-09-19, under 510(k) number K895235.

Who is the listed applicant for VARIOUS DISPOSABLE SURGICAL GARMENTS?

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

What is the FDA product code for VARIOUS DISPOSABLE SURGICAL GARMENTS?

The FDA product code for VARIOUS DISPOSABLE SURGICAL GARMENTS is FYE.

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

Related Devices (Code: FYE)

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.

K932731BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWNJohnson & Johnson Medical, Inc.K912790SURGICAL GOWNUnicor Federal Dept. of JusticeK910920PROTEKT GLOVESIntermedics OrthopedicsK910941LIFELINER SURGICAL GLOVEDepuy-RaynhamK895667STERILE SURGICAL GOWNClinitech, Inc.K894760CLOTHINGUARDBarrier Concepts, 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.

↑