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510(k) Data Aggregation
(118 days)
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
The proposed device Disposable Surgical Gowns have body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The Disposable Surgical Gowns are blue color, sterilized by ethylene oxide gas, single use and disposable medical device. The proposed device is available in S (115×140cm), M (120×150cm), L (130×160cm), XL (140×170cm), XXL (150×175cm), and XXXL (170×180cm).
This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
This document is a 510(k) Premarket Notification from the FDA for Disposable Surgical Gowns. It details the device, its intended use, comparison to a predicate device, and results of non-clinical tests.
Here's the breakdown of the acceptance criteria and study information, based on your request, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Seam strength (ASTM D1683M-17) | ASTM D1683M-17 | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (77.54 N) - Average result from 10 samples |
| Breaking strength (ASTM D5034-09) | ASTM D5034-09 (2017) | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (MD: 156.87N, CD: 125.20N) - Average result from 10 samples |
| Tear strength (ASTM D5587-15) | ASTM D5587: 2015(2019) | ≥10N | PASS (MD: 66.34N, CD: 38.44N) - Average result from 10 samples |
| Lint and other generation in the dry state (ISO 9073-10:2003(E)) | ISO 9073-10: 2003 | Log10(particle count) |
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