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510(k) Data Aggregation
(86 days)
Medline Disposable Sterile Surgical Gowns, Zoned Impervious are surgical apparel that is intended to be wom 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.
Medline Disposable Sterile Zoned Impervious Surgical Gowns are manufactured from a non-woven fabric which is laminated to a plastic film. Because the plastic film is made of microporous polyethylene, it provides protection from inward liquid penetration as well as comfort by allowing outward passage of vapor. These products are disposable and intended for single use only. The Sontara Spunlace Fabric is produced by DuPont. It is a hydroentangled (or hydrolaced) fabric made using a Spunlace technology. For medical applications, the content is approximately 55% wood pulp and 45% polyester. The interlaced fibers and surface finish give Sontara outstanding barrier properties while providing the comfort features of re-usable linens. This product has seams which are bound to provide strength and barrier properties. Tape is utilized to cover the drill holes required during manufacturing. There are long stockinet cuffs on the sleeves for added comfort and protection. Both Velcro and snaps are offered as closures. The materials used in Medline's gowns are strong, do not unravel or delaminate and are low in lint.
The provided text describes a 510(k) submission for Medline Disposable Sterile Zoned Impervious Surgical Gowns. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive independent clinical study data to prove the performance against a set of acceptance criteria in the way a diagnostic or therapeutic device might.
However, based on the information provided, we can infer acceptance criteria related to material properties and barrier performance. The "study" described is a set of non-clinical tests.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance Study for Medline Disposable Sterile Zoned Impervious Surgical Gowns
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Johnson & Johnson Medical, Inc.'s Barrier Fabric 450 Surgical Gown, K934608). The "acceptance criteria" are implied by the performance characteristics presented in comparison to the predicate, and the regulatory requirements for surgical gowns. The study conducted comprises non-clinical performance tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature (Implied Acceptance Criteria) | Standard/Method (if specified) | Predicate Device Performance (Reference) | Medline Device Performance (Reported) | Meets Criteria? |
|---|---|---|---|---|
| Material Composition | - | Non-woven hydroentangled fabric, spunlace technology | Sontara Spunlace – Non-woven hydroentangled fabric, spunlace technology | Yes (Functionally the same) |
| Weight Per Square Yard | - | 2.1 oz/yd² | 1.70 oz/yd² | Yes (Within acceptable range for equivalence) |
| Thickness | - | 10.0 mils | 9.4 mils | Yes (Within acceptable range for equivalence) |
| Viral Penetration | ASTM F1671 | Not explicitly listed, but implied predicate also meets this. | Tested under ASTM F1671 | Yes (Tested, implied compliance) |
| Synthetic Blood Penetration | ASTM F1670 | Not explicitly listed, but implied predicate also meets this. | Tested under ASTM F1670 | Yes (Tested, implied compliance) |
| Biocompatibility (Surface devices, intact skin, limited duration |
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