(49 days)
The 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 blue nitrile patient examination glove, tested for use with Chemotherapy drugs, that meets all the requirements of ASTM standard D6319, except for sterility requirements.
The provided documentation describes the acceptance criteria and performance of the "Blue Powder Free Nitrile Patient Exam Glove," a Class I medical device. This device is a patient examination glove used to prevent contamination between patient and examiner.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimension | ASTM D6319 | Meets |
| Physical Properties | ASTM D6319 | Meets |
| Freedom from Pinholes | ASTM D5151 & ASTM D6319 | Meets |
| Powder Residual | ASTM D6124 (acceptance criteria typically < 2mg/glove, implied by statement) | Meets (Results generated values below 2mg of residual powder.) |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10) | Gloves are non-irritating |
| Biocompatibility | Dermal Sensitization in the guinea pig (ISO 10993-10) | Gloves do not display any potential for sensitization |
Note: The standard ASTM D6319, ASTM D6124, and ASTM D5151 inherently contain specific acceptance limits for metrics like tensile strength, elongation, dimensions, freedom from holes, and powder residual. The document states the device "Meets" these standards, indicating compliance with all their respective criteria. For Powder Residual, a specific value is provided (<2mg), which is typically the acceptance criterion for powder-free gloves.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test (Dimension, Physical Properties, Pinholes, Powder Residual, Biocompatibility). The tests refer to ASTM and ISO standards, which would outline the appropriate sampling plans and methodologies.
The "data provenance" (country of origin, retrospective/prospective) is not provided in the document. The applicant, Northstar Healthcare Holdings, is based in Dublin, Ireland, and the official correspondent (Cypress Medical Products LLC) is in McHenry, IL, USA. However, the location where the testing was conducted is not specified. It is likely prospective testing as it's a product performance evaluation for a 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a patient examination glove, and its performance is evaluated against established physical and biocompatibility standards (ASTM D6319, D5151, D6124, ISO 10993-10) rather than requiring expert interpretation of diagnostic images or clinical outcomes. Therefore, the concept of "experts" establishing ground truth in the way it applies to diagnostic devices (e.g., radiologists interpreting images) is not applicable here. The "ground truth" is determined by objective measurements performed according to the specified standards by trained laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests involve objective measurements and adherence to industry standards, not subjective interpretations requiring adjudicated consensus.
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 disposable patient examination glove; it is not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on objective measurements against established national and international standards. These include:
- Physical Property measurements: e.g., tensile strength, elongation, dimensions as per ASTM D6319.
- Freedom from Pinholes: Determined by water leak tests as per ASTM D5151 and D6319.
- Powder Residual measurement: As per ASTM D6124.
- Biocompatibility testing: In-vivo assays (rabbit irritation, guinea pig sensitization) as per ISO 10993-10.
8. The sample size for the training set
Not applicable. This is a physical product, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, there is no ground truth established for a training set.
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K121 464
Abbreviated 510(k) Premarket Notification Blue Powder Free Nitrile Patient Exam Glove
Section 5, 510(k) Summary Pagc S-1
510(k) SUMMARY 5 JUL 5 2012 DATE: March 5, 2012 OWNER: Northstar Healthcare Holdings 70 Sir John Rogerson's Quay Dublin 2, Ireland OFFICIAL Alex Nagy CORRESPONDENT: Manager, Quality Systems and Regulatory Affairs Cypress Medical Products LLC 1200 South Route 31 McHenry, IL 60050 Telephone: 815-385-0100 Fax: 815-385-0114 Blue Powder Free Nitrile DEVICE NAME: Trade Name: Examination Glove Common Name: Patient Examination Gloves Classification : Patient Examination Gloves Class: Class I . Product Code: LZA PREDICATE DEVICE(S):
| Predicate510(k) | Device Name | Indication | ClearanceDate | Company |
|---|---|---|---|---|
| K071119 | Nitrile PowderFreeExaminationGloves (Blue,White) | The examination gloves is a disposable deviceintended for medical and dental purposes that isworn on the examiner's hand to preventcontamination between patient and examiner. | 24 Jul 2007 | GXCorporationSDN BHN,SelangorDarulEhsan,Malaysia |
Northstar Healthcare Holdings - Confidential
.
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Abbreviated 510(k) Premarket Notification Blue Powder Free Nitrile Patient Exam Glove
DEVICE DESCRIPTION:
STATEMENT OF
INTENDED USE:
Powder free blue nitrile patient examination glove, tested for use with Chemotherapy drugs, that meets all the requirements of ASTM standard D6319, except for sterility requirements.
The nitrile 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.
TECHNOLOGICAL CHARACTERISTICS:
The Blue Powder Free Nitrile Examination Glove is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with Nitrile using similar manufacturing processes.
ASSESSMENT OF NONCLINICAL DATA:
| Characteristic | Standard | Device Performance |
|---|---|---|
| Dimension | ASTM D6319 | Meets |
| Physical Properties | ASTM D6319 | Meets |
| Freedom from Pinholes | ASTM D5151 & ASTM D6319 | Meets |
| Powder Residual | ASTM 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 |
CONCLUSIONS:
The Blue Powder Free Nitrile Patient Exam Glove meet the requirements of established standards ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, and ISO 10993-10.
Based on the comparison of intended use, design, materials and performance, the Blue Powder Free Nitrile Patient Exam Glove are substantially equivalent to the predicate device.
Northstar Healthcare Holdings - Confidential
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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 stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three diagonal lines that form a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 0 2012
NorthStar Healthcare Holdings C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K121464
Trade/Device Name: Blue Powder Free Nitrile Patient Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 20, 2012 Received: June 21, 2012
Dear Mr. Devine:
This letter corrects our substantially equivalent letter of July 5, 2012.
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 (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.
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
For Beth Simmons
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): _K12 / 464
Blue Powder Free Nitrile Patient Exam Glove Device Name:
Indications for Use: The 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ I of _1
Elizabeth D. Clamin-Willis
:Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
::10(k) Number: ______________________________________________________________________________________________________________________________________________________________
19 of 127
§ 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.