(184 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
A Powder-Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880,6250). Our Powder-Free Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250. Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
The provided documentation describes the acceptance criteria and the study conducted for the Shandong Taixiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Non-Sterile.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
This device is a Class I medical device, and the demonstration of substantial equivalence relies on meeting established industry standards and FDA requirements for patient examination gloves.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Material / Physical Properties: | |
| ASTM D5250-06 (Standard Specification for Vinyl Patient Examination Gloves) | Conforms fully to ASTM D5250-06 standard |
| Barrier Integrity (Pinhole Detection): | |
| FDA 1000 ml Water Fill Test (AQL 2.5, Inspection Level I) | Meets these requirements |
| Powder Content: | |
| ASTM D6124-06 (Residual Powder Testing) | Less than 2mg/pc (meets "powder-free" claim) |
| Biocompatibility (Skin Safety): | |
| Primary Skin Irritation Test | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) Test | No sensitization reactions |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "samplings of AQL 2.5." While a specific numerical sample size for each test is not explicitly stated, "AQL 2.5" (Acceptable Quality Level 2.5) refers to a sampling plan for inspection. For example, for the FDA 1000ml Water Fill Test, "Inspection Level I" with AQL 2.5 would dictate the sample size based on the lot size. These are standardized sampling methodologies for quality control in manufacturing.
- Data Provenance: The tests were "conducted" by Shandong Taixiang Medical Products Co., Ltd. and their associated labs. The country of origin of the data is implicitly China, where the company is located. The studies are prospective in the sense that they are conducted on manufactured gloves to ensure they meet specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device. Ground truth for medical gloves is established by adherence to existing material standards (ASTM, FDA) and standardized test methods, not by expert consensus on clinical interpretation or image analysis. The "ground truth" is the objective measurement against these established standards.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements against predefined specifications. There is no subjective interpretation or need for adjudication by multiple parties for these types of tests (e.g., measuring powder content, water fill test for pinholes, or chemical irritation tests).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers interpret results, and the AI assists in that interpretation. For examination gloves, the performance is assessed through physical and chemical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used is primarily established industry standards and regulatory requirements. This includes:
- ASTM D5250-06 (Standard Specification for Vinyl Patient Examination Gloves)
- ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
- FDA 1000 ml Water Fill Test (for barrier integrity/pinholes)
- Biocompatibility testing guidelines (for primary skin irritation and sensitization)
These standards define the acceptable performance parameters for the device.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for this product is related to manufacturing processes to ensure consistent quality.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth" establishment in that context.
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K120230 1 of 2
Shandong Taixiang Medical Products Co., Ltd.
No.15, East Road, Hongrun Industry Park Oingzhou, Shandong, China
JUL 2 7 2012
510 (K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
Submitter's Identification: 1.
Shandong Taixiang Medical Products Co., Ltd. No.15, East Road, Hongrun Industry Park Oingzhou, Shandong, China
Contact Person:
Yin, Xiaohong Product Manager Phone Number: 011-86-5365768606
Date summary prepared: January 10, 2012
Name of the Device: 2.
Shandong Taixiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Non-Sterile
3. Predicate Device Informaton:
Shijiazhuang Star Plastic Co., Ltd. Vinyl Examination Gloves - Powder Free (K100699)
Tangshan Zhonghong Pulin Food Products Co., Ltd. Vinyl Examination Gloves - Powder Free (K022091)
4. Device Description:
A Powder-Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880,6250). Our Powder-Free Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250. Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
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Shandong Taixiang Medical Products Co., Ltd.
No.15, East Road, Hongrun Industry Park Oingzhou, Shandong, China
ડ. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Comparison to Predicate Devices: 6.
Shandong Taixiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves are substantially equivalent in safety and effectiveness to Tangshan Zhonghong Pulin Food Products Co., Ltd. (K022091) and Shijiazhuang Star Plastic., Co., Ltd. (K100699) Powder-Free Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Shandong Taixiang Medical Products Co., Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5. Inspection Level I, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Shandong Taixiang Medical Products Co., Ltd. Powder-Free Viny] Patient Examination Gloves conforms fully to ASTM-D-5250-06 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three tail feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shandong Taixiang Medical Products Company, Limited C/O Mr. Ray Zhou Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
Re: K120230
Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 29, 2012 Received: July 3, 2012
Dear Mr. Zhou:
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.
JUL 2 7 2012
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Page 2 - Mr. Zhou
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 yours,
Fo
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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Shandong Taixiang Medical Products Co., Ltd.
No.15, East Road, Hongrun Industry Park Qingzhou, Shandong, China
INDICATIONS FOR USE
Applicant: Shandong Taixiang Medical Products Co., Ltd.
K120230 510(k) Number:
Powder-Free Vinyl Patient Examination Gloves, Non-Sterile Device Name:
Indications of Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Prescription Use
Over the Counter Use X
Factory Initials
Elizabet P. Clain-Weller
(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120230
§ 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.