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Spunlace Reinforced Surgical Gown (Non-Sterile)-M

MEDTECS (TAIWAN) CORP. · Model JCSG84700M · UDI-DI 04710415369307

FYA

510(k) clearances

780

Adverse events

129

Recalls

225

Facilities

Description

The Spunlace Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The Spunlace Reinforced Gown is made from Spunlace material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) the chest area is reinforced with additional layer of SMS material. (b) the sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Recalls

Date	Firm	Reason
2026-01-28	Medline Industries, LP	Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in p
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2025-11-12	Cardinal Health 200, LLC	Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
2023-11-29	MEDLINE INDUSTRIES, LP - Northfield	Surgical gowns were manufactured with the wrong sleeve.
2022-10-31	Owens & Minor Distribution, Inc.	Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
2022-09-01	Texas Medical Technology Inc.	Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., bloo
2021-11-02	Cardinal Health	Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02	Cardinal Health	Potential for open packaging seals compromising the sterility of the surgical gowns

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.