← Product Code [KKX](/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX) · K955749 # TEX-CARE STERILE STOCKINETTE (K955749) _Flynt Amtex, Inc. · KKX · Nov 22, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K955749 ## Device Facts - **Applicant:** Flynt Amtex, Inc. - **Product Code:** [KKX](/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX.md) - **Decision Date:** Nov 22, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4370 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## 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. ## Regulatory 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) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K955749](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K955749) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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