(115 days)
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
The provided documents describe the performance of "Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Pink". This is a medical device classified as a Class I, 21 CFR 880.6250, Polymer Patient Examination Glove, 80 LZA.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Applicable FDA-Recognized Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319-00a (2005)e1 | Conforms to standard | Meets |
| Physical Properties | ASTM D 6319-00a (2005)e1 | Conforms to standard | Meets |
| Freedom from holes | ASTM D 6319-00a (2005)e1 | Conforms to standard | Meets |
| Residual Powder Test | ASTM D 6319-00a (2005)e1, ASTM D6124-06 | Conforms to standard | Meets |
| Primary Skin Irritation and Sensitization | ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3 | Conforms to standards | Meets |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. However, the tests are non-clinical (laboratory/material characteristic tests) and typically involve statistical sampling based on the specific ASTM or ISO standard requirements for batch testing. The data provenance is implied to be from the manufacturer's testing in support of their 510(k) submission, likely performed in China (country of origin of the manufacturer) and provided to the FDA. The tests are retrospective, meaning they were conducted on already manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation of exam gloves against ASTM and ISO standards involves objective laboratory measurements and tests, not subjective interpretation by human experts to establish ground truth. The "ground truth" is the established technical specification defined by the standards themselves.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to a process of resolving discrepancies among multiple human readers for subjective assessments (e.g., medical image interpretation). For the physical and chemical tests conducted on examination gloves, the results are quantitative or qualitative assessments against defined criteria, not 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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a disposable examination glove, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done. This question is also relevant for AI algorithms. The performance of the examination glove is measured by its physical and chemical properties and biocompatibility, not by an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is established by conformance to recognized industry standards (ASTM D 6319-00a (2005)e1, ASTM D6124-06, ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3). These standards define the acceptable range or limits for dimensions, strength, freedom from holes, residual powder, and biological response (skin irritation/sensitization).
8. The sample size for the training set
This information is not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as in point 8.
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EXHIBIT #1 Page 1 of 3
APR 2 1 2011
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR $807.92.
The assigned 510(K) number is: K103770
1. Owner's Identification:
Mr. Shen Xiaolin Syntex Healthcare Products Co., Ltd. No 1 Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, China 052360 Tel: 86-311-83980319
Submitter: Kathy Liu Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Date Summary Prepared: February 19, 2011
2. Name of the Device:
Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Pink Common Name: Exam Gloves
3. Predicate Device Information:
Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue (K070861)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
5. Intended Use of the Device:
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6. Comparison to Predicate Devices:
Syntex Healthcare Products Co., Ltd.'s Powder Free Nitrile Examination Glove, Pink is substantially equivalent in safety and effectiveness to the Hong Xin Rubber Products Co., Ltd's Powder Free Nitrile Examination Gloves, Blue.
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K103770
EXHIBIT #1 Page 2 of 3
| Technological Characteristics | Comparison Result |
|---|---|
| Intended use | Identical |
| Indications for use | Identical |
| Target population | Identical |
| Anatomical sites | Identical |
| Where used (hospital, home,ambulance, etc) | Identical |
| Energy used and/or delivered | Identical (Not applicable) |
| Human factors | Identical |
| Design | Similar |
| Performance | Identical |
| Standards met | Identical |
| Materials | Similar |
| Biocompatibility | Identical |
| Compatibility with the environmentand other devices | Identical |
| Sterility | Identical (Not applicable) |
| Electrical safety | Identical (Not applicable) |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Thermal safety | Identical (Not applicable) |
| Radiation safety | Identical (Not applicable) |
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
| Characteristics | Applicable FDA- RecognizedStandards | Performance Results |
|---|---|---|
| Dimensions | ASTM D 6319-00a (2005)e1 | Meets |
| Physical Properties | ASTM D 6319-00a (2005)e1 | Meets |
| Freedom from holes | ASTM D 6319-00a (2005)e1 | Meets |
| Residual Powder Test | ASTM D 6319-00a (2005)e1ASTM D6124-06 | Meets |
| Primary Skin Irritationand Skin Sensitization | ISO 10993 Part 1016CFR 1500.4116CFR 1500.3 | Meets |
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EXHIBIT #1 Page 3 of 3
8. Labeling:
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
9. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
10. Conclusions:
Syntex Healthcare Products Co., Ltd.'s Powder Free Nitrile Examination Glove, Pink conform fully to ASTM D6319-00a (2005)e1standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited. Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe and effective as the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Syntex Healthcare Products Company, Limited C/O Ms. Kathy Liu Project Manager Surprotect, Incorporated 3973 Schaefer Avenue Chino, California 91710
APR 2 1 2011
Re: K103770
Trade/Device Name: Powder-Free Nitrile Examination Glove, Pink Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 3, 2011 Received: March 14, 2011
Dear Ms. Liu:
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- Ms. Liu
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/ucm l 15809.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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Attachment A
INDICATION FOR USE
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
103770 Syntex I-lealthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Pink
INDICATIONS FOR USE:
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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AND/ OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter-Use _ イ (21CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
| Elizabeth H. F. Clamis William | |
|---|---|
| (Division Sign-Off) |
(Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103770
§ 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.