(86 days)
These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as non-invasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination.
The Duraprene Sterile Synthetic Surgical Gloves are formulated using neoprene and offered sterile.
This document describes the acceptance criteria and the summary of testing conducted for the Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "requirements" mentioned in the "Summary of Testing" section, primarily referencing ASTM D3577-91 and 21 CFR §800.20.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intracutaneous Reactivity | No irritation following intradermal injection of extracts. | Glove does not elicit irritation following intradermal injection of extracts. |
| Kligman Maximization Sensitization | No potential to produce skin sensitization. | Glove does not display potential to produce skin sensitization. |
| USP Mouse Systemic Test | No systemic response. | No systemic response was observed. |
| Ultimate Elongation & Tensile Strength | Meets or exceeds requirements for rubber surgical gloves per ASTM D3577-91. | Glove meets or exceeds requirements for rubber surgical gloves per ASTM D3577-91. |
| Barrier Defects | Meets or exceeds requirements per 21 CFR §800.20, AQL = 2.5 and ASTM D3577-91, AQL=1.5. | Glove meets or exceeds requirements per 21 CFR §800.20, AQL = 2.5 and ASTM D3577-91, AQL=1.5. |
| Powder Level | Meets powder level requirements for "Powder Free" designation (below 2mg/glove cornstarch level). | Gloves meet powder level requirements for "Powder Free" designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2mg/glove cornstarch level including. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. For "Ultimate Elongation & Tensile Strength" and "Barrier Defects," the reference to ASTM D3577-91 and 21 CFR §800.20 would imply standard sampling methods as defined by these regulations and standards. The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective), but it can be inferred that these are in-house laboratory tests conducted by the manufacturer as part of the 510(k) submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are primarily objective laboratory and biological evaluations, not requiring expert consensus for ground truth establishment in the way a diagnostic imaging device might.
4. Adjudication method for the test set
Not applicable. The tests are primarily objective measurements or biological assessments, not subjective interpretations requiring adjudication.
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 a medical device (surgical glove) and not an AI or diagnostic imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the tests is based on:
- Established standards: ASTM D3577-91 for mechanical properties and barrier defects, and 21 CFR §800.20 for barrier defects.
- Biological reactivity assays: Standardized tests like Intracutaneous Reactivity, Kligman Maximization Sensitization, and USP Mouse Systemic Test, which have defined endpoints for "no irritation," "no sensitization," and "no systemic response."
- Chemical analysis: For powder level, a vacuum filtration method combined with a negative iodine test against a defined threshold of 2mg/glove cornstarch.
8. The sample size for the training set
Not applicable. This is a physical medical device, and the concept of "training set" is not relevant in this context. The manufacturing process and quality control systems ensure consistency, rather than a data-driven training process.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for a physical device like a surgical glove. Quality control and adherence to manufacturing specifications ensure the product meets its intended design.
{0}------------------------------------------------
Image /page/0/Picture/3 description: The image shows the word "Allegiance" in a bold, stylized font. To the left of the word is a symbol that resembles a plus sign made up of small squares. The word is written in all capital letters and appears to be the logo for a company or organization.
JUL - 9 1997
510(k) SUMMARY K971381
| Manufacturer: | Allegiance Healthcare CorporationRoute 35 WestEaton, Ohio 45320 |
|---|---|
| Regulatory Affairs Contact: | Maryalice Smith1500 Waukegan Road, Bldg. KMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3322 |
| Date Summary Prepared: | March, 1997 |
| Product Trade Name: | Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgical |
| Predicate Devices: | Duraprene™ Sterile Synthetic Surgical Gloves |
| Description: | The Duraprene Sterile Synthetic Surgical Gloves are formulated usingneoprene and offered sterile. |
| Intended Use: | Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves areintended for use in sterile environments within hospitals andother healthcare facilities. The gloves are appropriate foruse during invasive surgical procedures and non-invasive medicalprocedures requiring sterility. They are intended to be worn byoperating room personnel to protect a surgical wound fromcontamination. These gloves are constructed from syntheticmaterials. They are intended to provide an alternative to wearers andpatients sensitive to natural rubber. |
{1}------------------------------------------------
Substantial Equivalence:
The Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves are substantially equivalent to powdered DurapreneTM Surgical Gloves in that they provide the following characteristics:
- intended use
- size, configuration, packaging
- made of synthetic materials
- tensile strength and thickness profiles
Summary of Testing:
| Test | Result |
|---|---|
| Intracutaneous Reactivity | Glove does not elicit irritation followingintradermal injection of extracts. |
| Kligman MaximizationSensitization | Glove does not displaypotential to produce skin sensitization. |
| USP Mouse Systemic Test | No systemic response was observed. |
| Ultimate Elongation& Tensile Strength | Glove meets or exceedsrequirements for rubbersurgical gloves perASTM D3577-91. |
| Barrier Defects | Glove meets or exceedsrequirements per 21 CFR§800.20, AQL = 2.5 andASTM D3577-91, AQL=1.5. |
| Data/Test Method | Gloves meet powder levelrequirements for "Powder Free"designation using the vacuum filtrationmethod plus a negative iodine test.Results generated values below the2mg/glove cornstarch level including |
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Maryalice Smith 'Requlatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. K McGaw Park, Illinois 60085
K971381 Re : Powder-Free Duraprene Sterile Synthetic Trade Name: Surqical Gloves Requlatory Class: I Product Code: KGO JUL - 9 1997 Dated: April 10, 1997 Received: April 14, 1997
Dear Ms. Smith:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 action. In addition, FDA may publish further announcements 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
{3}------------------------------------------------
Page 2 - Ms. Smith
through 542 of the Act for devices under the Electronic chrough 542 or the not of provisions, or other Federal laws or · regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberroom in postantial equivalence of your device to a legally marketed predicate device results in a classification for your markets production permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on compriation 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" (21 CFR 807.97). 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/dsmamain.html".
Sincerely yours,
K. Celatnids
Timo Why Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that looks like a plus sign made up of small squares. The word is in black and the background is white.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 917.473.1500
Page 1 of 1
| Applicant: | Allegiance Healthcare Corporation |
|---|---|
| 510(k) Number (if known): | K971381 |
| Device Name: | Powder-Free Duraprene TM Sterile Synthetic Surgical Gloves |
| Indications For Use: | These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as non-invasive activities requiring sterility. They are designed 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
| (Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|---|
| 510(k) Number | K971381 | |
| Prescription Use (Per 21 CFR 801.109) | or | Over-The Counter Use✓ |
§ 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).