(63 days)
These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.
The Ultrafree Textured Surgical gloves are formulated using natural rubber latex and offered powder-free and sterile.
The provided document describes the Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves (K983962). Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | Biocompatibility tests successfully performed on Ultrafree Surgical Gloves were considered applicable to Ultrafree Textured Surgical Glove since they are made using the same latex formulation and manufacturing process. |
| Primary Skin Irritation: | Gloves do not display any potential for irritation. |
| Systemic Toxicity: | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity: | Gloves show no reactivity. |
| Hemocompatibility: | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization (for potential sensitization): | Gloves do not display any potential for irritation. (Note: "irritation" is stated here, but guinea pig maximization test typically assesses sensitization. It's possible the document uses "irritation" broadly or has a slight imprecision in language for this specific test.) |
| Physical Properties: | |
| Ultimate Elongation & Tensile Strength: | Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-91. |
| Barrier Defects (Water Leak Test): | Gloves meet or exceed requirements per 21 CFR §800.20, AQL = 2.5. |
| Powder Level (for "Powder Free" designation): | Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove. (Acceptance criteria is implicitly < 2mg/glove as per ASTM D6124-97 for "powder-free" designation, or at least that the device met this standard). |
2. Sample size used for the test set and the data provenance
The document specifies test method standards (e.g., ASTM D3577-91, 21 CFR §800.20, ASTM D6124-97) but does not provide explicit sample sizes for the test sets used for each of these performance criteria.
Data Provenance: Not explicitly stated, but given the manufacturer is Allegiance Healthcare Sdn. Bhd. (Penang, West Malaysia) and the regulatory affairs contact is based in McGaw Park, IL, USA, the testing was likely conducted by or for the manufacturer, potentially in West Malaysia or the US. The results are presented for a 510(k) submission to the US FDA. The studies are retrospective as they were conducted to obtain regulatory clearance for an existing product design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a physical medical device (surgical gloves), not an AI/imaging device requiring expert interpretation of images. Therefore, the concept of "experts establishing ground truth for the test set" (as in clinical or radiological diagnosis) is not applicable. The "ground truth" for these tests is defined by the physical, chemical, and biological standards and their associated methodologies (e.g., ASTM standards, biocompatibility testing protocols).
4. Adjudication method for the test set
Not applicable. As this is a physical device tested against defined standards, there is no human adjudication process involved in assessing the primary performance metrics, unlike image interpretation or clinical trial endpoints. The results are quantitative measurements or qualitative observations based on laboratory assays and physical tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
The ground truth used for this device's performance evaluation is based on established industry standards and regulatory requirements for medical gloves. This includes:
- ASTM (American Society for Testing and Materials) Standards:
- ASTM D3577-91 for rubber surgical gloves (for ultimate elongation and tensile strength).
- ASTM D6124-97 for residual powder on medical gloves.
- Regulatory Standards:
- 21 CFR §800.20 for barrier defects (AQL = 2.5).
- Biocompatibility Standards: Implicitly, recognized International Organization for Standardization (ISO) standards for biocompatibility (e.g., ISO 10993 series) would guide these tests, though specific ISO standards are not cited in the summary. These tests ensure the material is not cytotoxic, irritating, sensitizing, or acutely toxic.
8. The sample size for the training set
Not applicable. This is a physical medical device that does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" for this type of device. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science, and prior regulatory and industry best practices for similar devices.
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8 1999 JAN
! 上
XIV. SUMMARY OF SAFETY AND EFFECTIVENESS
Allegiance
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES
| Manufacturer: | Allegiance Healthcare Sdn. Bhd.Plot 87, Kampung Jawa11900 Bayan LepasPenang, West Malaysia |
|---|---|
| Regulatory Affairs Contact: Erica Sethi | Allegiance Healthcare Corporation1500 Waukegan Road, Bldg. KMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3337 |
| Date Summary Prepared: | October 21, 1998 |
| Product Trade Name: | Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Ultrafree Sterile Latex Powder-Free Surgical Gloves |
| Description: | The Ultrafree Textured Surgical gloves are formulated usingnatural rubber latex and offered powder-free and sterile. |
| Intended Use: | Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves areintended for use in environments within hospitals and otherhealthcare facilities. The gloves are appropriate for use duringinvasive and non-invasive medical procedures requiring sterility.They are intended to be worn by operating room personnel toprotect a surgical wound from contamination. |
| Substantial Equivalence: | The Ultrafree Textured Sterile Latex Powder-Free Surgical Glovesare substantially equivalent to Ultrafree Sterile Latex Powder-FreeSurgical Gloves in that they provide the following characteristics:- same intended use- same sizes, configuration, packaging- both made of natural rubber latex- same tensile strength and thickness profiles |
| Summary of Testing: | |
| Test | Result |
| Primary SkinIrritation | Biocompatability tests successfully performed on Ultrafree SurgicalGloves were considered applicable to Ultrafree Textured SurgicalGlove since they are made using the same latex formulation andmanufacturing process. Gloves do not display any potential forirritation. |
| Systemic Toxicity | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | Gloves show no reactivity. |
| Hemocompatibility | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Ultimate Elongation& Tensile Strength | Gloves meet or exceed requirements for rubber surgical glovesper ASTM D3577-91. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR§800.20, AQL = 2.5. |
| Data/Test Method | Gloves meet powder level requirements for "Powder Free"designation using ASTM Standard D6124-97-Standard test methodfor residual powder on medical gloves. Results generated valuesbelow 2 mg of residual powder per glove. |
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K983962
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Image /page/2/Picture/2 description: The image shows a partial view of a logo or emblem, featuring a stylized graphic element on the left. The graphic consists of three curved lines or shapes stacked vertically, resembling a simplified representation of a wing or a flowing object. To the right of the graphic, there is a partial word or name, with only the letters 'DEPART' visible. The overall impression is that of an official or organizational symbol, possibly related to a department or agency.
1000 JAN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Erica Sethi Allegiance Healthcare Corporation 1500 Waukegan Road, Building K McGaw Park, Illinois 60085
Re: K983962 Ultrafree Textured Sterile Latex Powder-Free Trade Name: Surgical Gloves Requlatory Class: I Product Code: KGO Dated: December 16, 1998 December 17, 1998 Received:
Dear Ms. Sethi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Sethi
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21CFR 807.97). Other genera Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmanain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that looks like a plus sign made up of small squares. The word is written in a bold, sans-serif font, with the letters slightly slanted to the right. The overall impression is one of strength and stability.
..............................................................................................................................................................................
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
Page 1 of 1
| Applicant: | Allegiance Healthcare Corporation |
|---|---|
| 510(k) Number: | K983962 |
| Device Name: | Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves |
| Indications For Use: | These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use(Per 21 CFR 801.109) | or |
| Over The Counter Use | |
| (Division Sign-Off) | |
| Division of Dental, Infection Control |
Division of Dental, Infection, Et
and General Hospital Device:
510(k) Number K983662
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).