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FDA 510(k)

COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)

K-Number: K010799 · 2001-06-07

ApplicantStandard Textile Co., Inc.
Decision Date2001-06-07
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) is the device name listed in this FDA 510(k) record. The listed applicant is Standard Textile Co., Inc.. It received FDA 510(k) clearance on 2001-06-07 under 510(k) number K010799. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)?

COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) is a medical device that received FDA 510(k) clearance on 2001-06-07. The listed applicant is Standard Textile Co., Inc.. The 510(k) number is K010799.

When did COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) receive FDA 510(k) clearance?

COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) received FDA 510(k) clearance on 2001-06-07, under 510(k) number K010799.

Who is the listed applicant for COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)?

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

What is the FDA product code for COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)?

The FDA product code for COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) is FYA.

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Other records listing Standard Textile Co., Inc. as applicant

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Related Devices (Code: FYA)

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.

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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.

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