(34 days)
The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Latex Patient Exam Glove, Smooth and Textured Natural Color (Off White) with Protein Labeling Claim (50 µg/dm² or less of water soluble protein)
Acceptance Criteria and Device Performance for Powder Free Latex Patient Exam Glove
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM Standard D3578 | Meets |
| Physical Properties | ASTM Standard D3578 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151 | Meets |
| Powder Residual | ASTM Standard D6124 (specifically, < 2 mg per glove) | Meets (Results generated values below 2 mg of residual powder) |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10); Dermal Sensitization in the guinea pig (ISO 10993-10) | Gloves are non-irritating; Gloves do not display any potential for sensitization |
| Residual Protein Levels | ASTM Standard D5712 (specifically, ≤ 50 µg/dm² of water soluble protein) | Meets (Protein Labeling Claim: 50 µg/dm² or less of water soluble protein) |
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, the tests are conducted according to recognized ASTM and ISO standards, which typically specify appropriate sample sizes for such evaluations.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted to meet the defined standards. The submission is for a Traditional 510(k), implying testing was performed to demonstrate substantial equivalence.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a medical glove, and its performance is evaluated against engineering and biological standards, not through expert-driven image or data interpretation.
4. Adjudication Method
Not applicable. Performance is based on objective laboratory testing against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a medical glove, and its performance is evaluated against engineering and biological standards, not typically through MRMC studies.
6. Standalone Performance (Algorithm Only)
Not applicable. This is a physical device (medical glove), not an algorithm or software.
7. Type of Ground Truth Used
The ground truth for this device is based on established industry standards and regulatory requirements. This includes:
- ASTM Standards: D3578 (dimensions, physical properties), D5151 (freedom from pinholes), D6124 (powder residual), D5712 (residual protein levels).
- ISO Standard: 10993-10 (biocompatibility - irritation and sensitization).
- CFR Regulations: 21 CFR 800.20 (freedom from pinholes).
8. Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of an AI or machine learning model. Performance is evaluated through laboratory testing of manufactured gloves.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device. The "ground truth" for evaluating the device's performance is defined by the requirements of the internationally recognized and regulatory standards listed above.
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KII2988
Traditional 510(k) Premarket Notification Powder Free Latex Patient Exam Glove, Textured & Smooth
510(k) Summary Page 1 NOV - 9 2011
510(k) SUMMARY
| DATE: | June 30, 2011 |
|---|---|
| OWNER: | Northstar Healthcare HoldingsHamilton House10 Queen StreetHamilton, Bermuda HM11 |
| OFFICIALCORRESPONDENT: | Michael RiordanNorthstar Healthcare Holdings Limited3300 Cork Airport Business Park, Kinsale RoadCork, IrelandTelephone: 353 21 4548255Fax: 353 21 4548294 |
| DEVICE NAME: | Trade Name: Powder Free Latex Patient Exam Glove, Smoothand Textured Natural Color (Off White) with ProteinLabeling Claim (50 $\mu$ g/dm² or less of water soluble protein |
| Common Name: Patient Examination Gloves | |
| Classification: Patient Examination Gloves | |
| Class: Class I | |
| Product Code: LYY |
PREDICATE DEVICE(S):
| Predicate510(k) | Device Name | Indication | ClearanceDate | Company |
|---|---|---|---|---|
| K932521 | Powder Free LatexExamination Gloves | The patient examination glove is adisposable device intended for medicalpurposes that is worn on the examiner's handto prevent contamination between patient andexaminer. | 13 Dec 1994 | Top GloveSDN.BHD.SelangorDarulEhsan,Malaysia |
| DEVICEDESCRIPTION: | Powder Free Latex Patient Exam Glove, Smoothand Textured Natural Color (Off White) with ProteinLabeling Claim (50 µg/dm² or less of water soluble protein) |
|---|---|
| ------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Traditional 510(k) Premarket Notification Powder Free Latex Patient Exam Glove, Textured & Smooth
510(k) Summary Page 2
STATEMENT OF INTENDED USE:
The latex examination glove is a disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for residual protein levels in accordance with ASTM D5712 Standard and contain 50µg/dm2 or less of water soluble protein.
TECHNOLOGICAL CHARACTERISTICS:
The Powder Free Latex Patient Exam, Textured and Smooth with Protein Labeling Claim is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with latex using similar manufacturing processes.
ASSESSMENT OF NONCLINICAL DATA:
| Characteristic | Standard | Device Performance |
|---|---|---|
| Dimension | ASTM Standard D3578 | Meets |
| Physical Properties | ASTM Standard D3578 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151 | Meets |
| Powder Residual | ASTM Standard D6124 | MeetsResults generatedvalues below 2mg ofresidual powder |
| Biocompatibility | Primary Skin Irritation in rabbits(ISO 10993-10)Dermal Sensitization in the guineapig (ISO 10993-10) | Gloves are non-irritatingGloves do not displayany potential forsensitization |
| Residual Protein Levels | ASTM Standard D5712 | Meets |
CONCLUSIONS:
The Powder Free Latex Patient Exam Gloves meet the requirements of established standards ASTM D3578-05, ASTM D6124-06, ASTM D5151-06, ASTM D5712-05e and ISO 10993-10.
Based on the comparison of intended use, design, materials and performance, the Powder Free Latex Patient Exam Gloves, Textured and Smooth, With Protein Labeling Claim are substantially equivalent to the predicate device.
Northstar Healthcare Holdings
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Northstar Healthcare Holding Limited C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
NOV - 9 2011
Re: K112988
Trade/Device Name: Powder Free Latex Patient Exam Glove, Smooth and Textured. Natural Color (Off White) with Protein Labeling Claim (50ug/dm2 or less of water soluble protein)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I
Product Code: LYY
Dated: October 26, 2011
Received: October 27, 2011
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 (OS) 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 vours.
Wh 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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Indications for Use
510(k) Number (if known): K112988
Device Name: Powder Free Latex Patient Exam Glove, Smooth and Textured Natural Color (Off White) with Protein Labeling Claim (50 µg/dm² or less of water soluble protein)
Indications for Use: The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elith F. Clamens Wills
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112988
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.