(115 days)
Not Found
No
The document describes a standard patient examination glove and does not mention any AI or ML capabilities.
No
The device is a patient examination glove, which is intended to prevent contamination between patient and examiner, not to provide therapeutic benefit.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic.
No
The device is a physical patient examination glove, which is a hardware device, not software. The description focuses on physical properties and testing of the glove material.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The device is classified as a "Polymer Patient Examination Glove" and is regulated under 21 CFR 880.6250. This classification is for general medical devices, not IVDs.
- Lack of Diagnostic Elements: The description and performance studies focus on physical properties, barrier integrity, and biocompatibility. There are no mentions of analyzing biological samples, detecting analytes, or providing diagnostic information.
- No Mention of IVD-Specific Regulations: The document references regulations and standards relevant to medical gloves (like ASTM D 6319), not those specific to IVDs.
In summary, the device is a physical barrier used during patient examination, which is a different category of medical device than an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
LZA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Identical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed for Determination of Substantial Equivalence:
- 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)e1, ASTM D6124-06, Meets
- Primary Skin Irritation and Skin Sensitization: ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3, Meets
Clinical Tests Performed: Not Applicable - There is no hypoallergenic Claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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 environment | |
| and 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- Recognized
Standards | 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)e1
ASTM D6124-06 | Meets |
| Primary Skin Irritation
and Skin Sensitization | ISO 10993 Part 10
16CFR 1500.41
16CFR 1500.3 | Meets |
2
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.
3
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.
4
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
5
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