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)

POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS

K-Number: K925077 · 1993-08-16

ApplicantMedtek Development Corp.
Decision Date1993-08-16
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS is the device name listed in this FDA 510(k) record. The listed applicant is Medtek Development Corp.. It received FDA 510(k) clearance on 1993-08-16 under 510(k) number K925077. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS?

POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS is a medical device that received FDA 510(k) clearance on 1993-08-16. The listed applicant is Medtek Development Corp.. The 510(k) number is K925077.

When did POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS receive FDA 510(k) clearance?

POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS received FDA 510(k) clearance on 1993-08-16, under 510(k) number K925077.

Who is the listed applicant for POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS?

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

What is the FDA product code for POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS?

The FDA product code for POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS is FYC.

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 Medtek Development Corp. 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.

K930026POLY-MED DISPOSABLE PERSONAL PROTECTION KIT

Related Devices (Code: FYC)

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.

K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC

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.

↑