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FDA 510(k)

DISPOSABLE BOUFFANT CAP

K-Number: K913700 · 1991-10-04

ApplicantGem Nonwovews, Inc.
Decision Date1991-10-04
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE BOUFFANT CAP is the device name listed in this FDA 510(k) record. The listed applicant is Gem Nonwovews, Inc.. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K913700. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE BOUFFANT CAP?

DISPOSABLE BOUFFANT CAP is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Gem Nonwovews, Inc.. The 510(k) number is K913700.

When did DISPOSABLE BOUFFANT CAP receive FDA 510(k) clearance?

DISPOSABLE BOUFFANT CAP received FDA 510(k) clearance on 1991-10-04, under 510(k) number K913700.

Who is the listed applicant for DISPOSABLE BOUFFANT CAP?

The FDA 510(k) record lists Gem Nonwovews, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE BOUFFANT CAP?

The FDA product code for DISPOSABLE BOUFFANT CAP is FYF.

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 Gem Nonwovews, Inc. 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.

K913628DISPOSABLE SHOE COVER

Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954454NIOMED SURGICAL HOODAmerasia Corp.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, 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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