(64 days)
These powder-free sterile surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.
Gloves are formulated using neoprene. They are coated with nitrile coating and are offered powder-free and sterile.
Here's a breakdown of the acceptance criteria and the study information for the Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating, based on the provided text:
Based on the provided 510(k) summary, this document describes a device for general medical use (surgical gloves), not an AI/ML-based device. Therefore, many of the requested fields related to AI/ML studies, such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, and how ground truth was established, are not applicable to this submission. The "study" here refers to standard performance testing for medical gloves.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating
| Test / Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization (Sensitization Potential) | Gloves do not display any potential for sensitization. |
| Dimensions (meets requirements of ASTM D3577) | Gloves meet requirements of ASTM D3577. |
| Physical Characteristics (Tensile Strength, Elongation, etc.) (meets requirements for rubber surgical gloves per ASTM D3577) | Gloves meet requirements for rubber surgical gloves per ASTM D3577. |
| Freedom from Holes (meets requirements of 21 CFR 800.20 and ASTM D3577) | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual (meets powder level requirements for "Powder-Free" designation per ASTM D3577, tested using ASTM standard D6124 - below 2mg/glove) | Results generated values below 2mg of residual powder per glove, meeting powder level requirements for "Powder-Free" designation per ASTM D3577 tested using ASTM standard D6124, Standard test method for residual powder on medical Doves. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for each test. Testing for medical gloves typically involves sampling a certain number of gloves from production lots according to relevant ASTM standards (e.g., ASTM D3577 for physical properties and freedom from holes, ASTM D6124 for powder residual).
- Data Provenance: The manufacturing location is listed as "7/111 Moo 4, Highway 331 Mabyangporn Pluakdaeng, Rayong, 21140, Thailand." The data is likely prospective testing performed on manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI/ML device where expert ground truth is established in the same manner. The "ground truth" for glove performance is determined by adherence to established governmental regulations (21 CFR 800.20) and industry standards (ASTM D3577, ASTM D6124), often through instrumental measurements and standardized methods rather than expert consensus on complex interpretations.
4. Adjudication method for the test set
- Not Applicable. No adjudication method, such as 2+1 or 3+1, is mentioned or would be relevant for these types of physical and chemical tests on surgical gloves. Performance is assessed against quantitative thresholds defined by standards.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used
- The ground truth for this device is based on established regulatory requirements (21 CFR 800.20) and recognized industry performance standards (ASTM D3577, ASTM D6124). These standards define the acceptable range or threshold for specific physical and chemical properties of the gloves.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
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CardinalHealth
NOV - 4 2010
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS K /0 25 OO
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
| Manufacturer: | Cardinal Healthcare 222 LTD.7/111 Moo 4, Highway 331 Mabyangporn Pluakdaeng,Rayong, 21140, Thailand |
|---|---|
| Regulatory Affairs Contact: | Tatyana Bogdan, RAC |
Regulatory Affairs Contact: Tatyana Bogdan, RAC Cardinal Health, Inc. 1430 Waukegan Road McGaw Park, IL 60085
| Telephone: | 847-887-2325 |
|---|---|
| ------------ | -------------- |
July 15, 2010 Date Summary Prepared:
Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Product Trade Name: Coating
Common Name: Surgeon's Gloves
Surgeon's Gloves Classification Name:
Gloves are formulated using neoprene. They are coated with nitrile Device Description: coating and are offered powder-free and sterile.
- · Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Intended Use: Coating are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.
- Sterile Synthetic Neoprene Powder-Free Surgical Gloves Predicate Devices: previously cleared under 510(k) K013302 (product code KGO);
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K102500
| Substantial Equivalence: | Sterile Neoprene Powder-Free Surgical Gloves with NitrileCoating are substantially equivalent to the predicate deviceidentified in this 510(k) summary. Substantial equivalence can beestablished in regard to intended use, physical characteristics,design and product features. Both gloves are made of neoprene andare coated with Nitrile. They use similar manufacturing processes. |
|---|---|
| Performance Testing: | |
| Test: | Result: |
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Dimensions | Gloves meet requirements of ASTM D3577. |
| Physical Characteristics | Gloves meet requirements for rubber surgical gloves per ASTMD3577. |
Gloves meet requirements of 21 CFR 800.20 and ASTM D3577 Freedom from Holes
Gloves meet powder level requirements for "Powder-Free" Powder Residual designation per ASTM D3577 tested using ASTM standard D6124, Standard test method for residual powder on medical Doves. Results generated values below 2mg of residual powder per glove.
No clinical data is required. Clinical Data:
. .
The Synthetic Neoprene Powder-Free Surgical Gloves with Nitrile Conclusion: The Dynaneet the technological characteristics of ASTM D3577 performance standard and are substantially equivalent to the predicate device identified in this 510(k) summary.
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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 features a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062-2096
NOV - 4 2010
Re: K102500
Trade/Device Name: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: October 20, 2010 Received: October 21, 2010
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Mr. Devine
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NoV . - 4 2010
Indications for Use
510(k) Number (if known): )</02500
Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Device Name:
These powder-free sterile surgeon's gloves are a disposable device made Indications for Use: of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E. Elizabeth R. Levine-Walls
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K 102500
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)
5
§ 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).