Who is the manufacturer of TEX-CARE STERILE STOCKINETTE?

Flynt Amtex, Inc. filed the 510(k) submission for TEX-CARE STERILE STOCKINETTE (K955749).

What is the FDA product code for TEX-CARE STERILE STOCKINETTE?

KKX. It is classified under 21 CFR 878.4370 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for TEX-CARE STERILE STOCKINETTE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TEX-CARE STERILE STOCKINETTE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TEX-CARE STERILE STOCKINETTE

K955749 · Flynt Amtex, Inc. · KKX · Nov 22, 1996 · General, Plastic Surgery

Device Facts

Record ID	K955749
Device Name	TEX-CARE STERILE STOCKINETTE
Applicant	Flynt Amtex, Inc.
Product Code	KKX · General, Plastic Surgery
Decision Date	Nov 22, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4370
Device Class	Class 2

Intended Use

Sterile stockinette is used primarily as an surgical extremity drape to establish a sterile field. Bias cut sterile stockinette is used as a dressing retainer where swelling is expected.

Device Story

Sterile stockinette (single/double ply rolls, bias cut, impervious) used as surgical extremity drape to establish sterile field; bias cut version used as dressing retainer for swelling. Device provides physical barrier/containment. Used in surgical settings by clinical staff. Benefits include maintenance of sterile field and support for dressing applications.

Clinical Evidence

Bench testing only. ASTM ES 21 (synthetic blood penetration) and ASTM ES 22 (viral penetration) passed on 32 samples. Biocompatibility: USP Intracutaneous (no irritation), USP Systemic Injection (no toxicity), Guinea Pig Maximization (0% sensitization). Mechanical: ASTM D 5034-90 (breaking force) and ASTM D 3787-89 (bursting strength) confirmed adequate strength. Flammability: CS-191-53 Part 1610 (Class 1 Normal Flammability).

Technological Characteristics

Textile-based stockinette (single/double ply, bias cut, impervious). Materials tested for biocompatibility (USP) and mechanical strength (ASTM D 5034-90, ASTM D 3787-89). Impervious variants tested for barrier performance (ASTM ES 21, ASTM ES 22). Flammability meets CS-191-53 Part 1610.

Indications for Use

Indicated for use as a surgical extremity drape to establish a sterile field or as a dressing retainer for patients where swelling is expected.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

Burlington Sterile Stockinette (also known as Balfour Sterile Stockinette) (K82270)

Related Devices

K031287 — STERI-DRAPE SURGICAL DRAPES · 3M Company · Sep 10, 2003
K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX · Foshan Nanhai Plus Medical Co, Ltd. · Jun 24, 2015
K030365 — DEROYAL DRAPES, STERILE, NON-STERILE · Deroyal Industries, Inc. · Apr 29, 2003
K101688 — EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 · Exact Medical Manufacturing, Inc. · Sep 20, 2010
K043015 — 3L SURGICAL DRAPES · 3l Medical Products Co., Ltd. · Aug 15, 2005

Submission Summary (Full Text)

{0} NOV-22-96 FRI 09:52 FLYNT AMTEX INC FAX NO. 9192267220 P. 02 NOV 22 1996 K955749 # 510 (K) Summary 11-22-96 Trade Name - Tex-Care Sterile Stockinette Common Name - Sterile Stockinette Classification Name - Drape, Surgical Predicate Device : Burlington*Sterile Stockinette also known as Balfour Sterile Stockinette 510 (K) K82270 Description: Sterile stockinette includes single and double ply rolls, bias cut rolls and impervious stockinette in various widths and lengths. Intended Use: Sterile stockinette is used primarily as an surgical extremity drape to establish a sterile field. Bias cut sterile stockinette is used as a dressing retainer where swelling is expected. Technical Characteristics: Tex-Care Sterile Stockinette has the same technological characteristics as the predicate device with regard to design, materials, and method of manufacture. The following tests were run on Tex-Care Sterile Stockinettes to indicate that they would function in a safe and effective manner. ASTM ES 21 - Synthetic Blood Penetration Test was run on 32 samples of impervious stockinettes to substantiate the claim of being impervious. All samples passed. ASTM ES 22 - Viral Penetration Test was run on 32 samples of impervious stockinettes to substantiate the claim of being impervious. All samples passed. Biocompatibility testing: USP Intracutaneous Test - This test was to determine if any chemicals that may leach or be extracted from the impervious stockinettes were capable of causing local irritation in the dermal tissues of the rabbit. No apparent irritation was observed in association with the test article extracts. {1} No.-22-96 FRI 09:52 FLYNT AMTEX INC FAX NO. 9192267220 P. 03 Re: Tex-Care Sterile Stockinette 510 (k) Summary Biocompatibility Testing Continued: USP Systemic Injection Test was run to screen the extracts of the impervious stockinette for potential toxic effects as a result of a single dose injection. None of the test animals showed any clinical signs consistent with toxicity at any time during the observation period. Guinea Pig Maximization Test (Sensitization) (Magnusson-Kligman) was run to evaluate the allergic potential or sensitizing capacity of the impervious stockinettes. The impervious stockinette showed a 0% sensitization incidence. ASTM D 5034-90 Standard Test Method for Breaking Force of Textile Fabric and ASTM D 3787-89 Bursting Strength of Knitted Goods (CRT) Ball Burst Test were performed on the stockinettes to indicate that the construction had adequate strength to perform as intended. Both burst strength and breaking force were shown to be adequate. CS-191-53 Part 1610 Flammability of Clothing Textiles tests indicated that requirements of Classification 1 - Normal Flammability were met by both cotton and impervious stockinettes. John A. Kranaskas Operations Manager Tex-Care Medical 673 Gilmer St. Burlington, NC 27417 910-570-5870