(29 days)
Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. The gloves are appropriate for use during invasive and non-invasive medical procedures requiring sterility.
These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for uses during invasive as well as non-invasive surgical procedures requiring sterlity. They are intended to be worn by operating room personnel to protect a surgical wound from contamination
Ultrafree Plus Powder-Free Surgical gloves are formulated using natural rubber latex and offered sterile.
The provided text describes the safety and effectiveness of Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves. It includes a summary of testing conducted to demonstrate their performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied by standard/regulation) | Reported Device Performance |
|---|---|---|
| Systemic Toxicity | No toxic reactions to acute application | Glove does not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | No reactivity observed | No reactivity was observed. |
| Guinea Pig Maximization | No potential for irritation | Glove does not display any potential for irritation. |
| Ultimate Elongation & | Meets or exceeds requirements per ASTM D3577-99 | Glove meets or exceeds requirements for rubber surgical gloves per ASTM D3577-99. |
| Tensile Strength | ||
| Barrier Defects | Exceeds requirements per 21 CFR §800.20, AQL = 2.5 | Glove exceeds requirements per 21 CFR §800.20, AQL = 2.5. |
| Residual Powder Level | Less than 4.0 mg per glove (in 1999) | Results generated values below 4 mg of powder residue per glove. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (Systemic Toxicity, Intracutaneous Reactivity, Guinea Pig Maximization, Ultimate Elongation & Tensile Strength, Barrier Defects, Residual Powder Level). These are standard product performance tests for medical devices. The data provenance is derived from testing conducted by the manufacturer, Allegiance Healthcare Sdn. Bhd., as part of their 510(k) submission to the FDA. The tests are retrospective in nature, performed on finished glove products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a surgical glove, and its performance is evaluated through objective physical and biological tests against established standards (e.g., ASTM, FDA regulations, ISO biocompatibility standards). Expert ground truth is not typically established for this type of device performance evaluation.
4. Adjudication method for the test set:
Not applicable. The tests involve objective measurements and established protocols, not subjective assessment 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 device is a surgical glove and does not involve AI or human readers for its intended use or performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device 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 performance criteria is based on:
- Established industry standards: ASTM D3577-99 for physical properties, ASTM D6124-97 for residual powder.
- FDA regulations: 21 CFR §800.20 for barrier defects (AQL).
- Biocompatibility testing guidelines: Implied for Systemic Toxicity, Intracutaneous Reactivity, and Guinea Pig Maximization, typically following ISO 10993 series or equivalent.
These standards and regulations define the acceptable performance limits for surgical gloves.
8. The sample size for the training set:
Not applicable. This device is a physical product and does not involve machine learning algorithms or training sets.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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JUL 13 1999
XIV. SUMMARY OF SAFETY AND EFFECTIVENESS
Allegrance
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ULTRAFREE PLUS STERILE LATEX POWDER-FREE SURGICAL GLOVES
| Manufacturer: | Allegiance Healthcare Sdn. Bhd.Plot 87, Kampung Jawa11900 Bayan LepasPenang, West Malaysia |
|---|---|
| Regulatory Affairs Contact: | Erica SethiAllegiance Healthcare Corporation1500 Waukegan Road, MP-WMMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3337 |
| Date Summary Prepared: | 7/8/99 |
| Product Trade Name: | Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgical |
| Predicate Devices: | Ultrafree Sterile Latex Powder-Free Surgical Gloves |
| Description: | Ultrafree Plus Powder-Free Surgical gloves are formulatedusing natural rubber latex and offered sterile. |
| Intended Use: | Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves are intendedto be worn by operating room personnel to protect a surgical woundfrom contamination. The gloves are appropriate for use duringinvasive and non-invasive medical procedures requiring sterility. |
| Substantial Equivalence: | Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves aresubstantially equivalent to Ultrafree Sterile Latex Powder-FreeSurgical Gloves in that they provide the following characteristics:- intended use- size, configuration, packaging- made of natural rubber latex- tensile strength and elongation |
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Summary of Testing:
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| Test | Result |
|---|---|
| Systemic Toxicity | Glove does not elicit anytoxic reactions to acuteapplication. |
| Intracutaneous Reactivity | No reactivity was observed. |
| Guinea Pig Maximization | Glove does not display anypotential for irritation. |
| Ultimate Elongation& Tensile Strength | Glove meets or exceedsrequirements for rubbersurgical gloves perASTM D3577-99. |
| Barrier Defects | Glove exceeds requirementsper 21 CFR §800.20, AQL = 2.5. |
| Data/Test Method | Glove meets powder levelrequirements for "Powder Free"designation using ASTM StandardD6124-97-Standard test method forresidual powder on medical gloves,Results generated values below4 mg of powder residue per glove.The specification limit for the amount ofpowder residue for this product in theyear 1999 will be less than 4.0 mg andwill be reduced by 1.0 mg each yearuntil a final limit of not more than 2.0mg is achieved in accordance withASTM D3577-99. |
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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces, and three wavy lines below, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 13 1999
Ms. Erica Sethi Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road 60085 McGaw Park, Illinois
K991992 Re : Ultrafree Thick Sterile Latex Powder-Free Trade Name: Surgical Gloves Requlatory Class: I Product Code: KGO Dated: June 8, 1999 Received: June 14, 1999
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 devices marketed in interstate abe beated in the env 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 against 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. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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Page 2 - Ms. Sethi
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as inforibed in your 510(k) premarket notification. The FDA debtired in jour ------------------------------------------------------------------------------------------------------------------------------------------------------------marketed predicate device results in a classification for your markets predications wour 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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene orgulation entitled, "Misbranding by reference to ene regaration" (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,
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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Allegiance
Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, Winois 60085-6787
847.473.1500
FAX: 847,785,2460
Page 1 of 1
Applicant: Allegiance Healthcare Corporation
510(k) Number (if known): K991992
Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves Device Name:
These gloves are intended for use in environments within hospitals Indications For Use: and other healthcare facilities. The gloves are appropriate for uses during invasive as well as non-invasive surgical procedures requiring sterlity. They are intended to be worn by operating room personnel to protect a surgical wound from contamination
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use (Per 21 CFR 801.109) | or | Over-The Counter Use X |
|---|---|---|
| --------------------------------------- | ---- | ------------------------------------------------------------------------- |
| (Division Sign-Off) |
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| Division of Dental, Infection Control, and General Hospital Devices |
| 510(k) Number | K991992 |
|---|---|
| --------------- | --------- |
§ 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).