(198 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.
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.
Here's a breakdown of the acceptance criteria and study information for the Powder Free Vinyl Patient Examination Gloves based on the provided 510(k) summary:
This device is a Class I medical device (21 CFR 880.6250) and a patient examination glove, which is generally subject to general controls and performance standards, rather than an AI/software device that would require the typical studies you've asked about (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts, training set details). The "studies" for this device relate to physical and biological testing to ensure safety and conformance to recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Test Performed | Reported Device Performance/Result |
|---|---|---|
| ASTM D5250-06 (Dimension) | Dimensional testing | Meets requirements |
| ASTM D5250-06 (Physical Property) | Physical property testing | Meets requirements |
| ASTM D5151-06 (Free of Pinhole) | FDA 1000 ml Water Fill Test (AQL 2.5, G-1) | Meets requirements |
| ASTM D6124-06 (Residual Powder) | Residual powder testing | < 2 mg/pc (meets "powder-free" claim) |
| Biocompatibility | Primary Skin Irritation and Dermal Sensitization | Not an irritant, not a sensitizer |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for each specific test in the format typically requested for AI/software model testing.
- Pinhole Test: For the FDA 1000 ml Water Fill Test (ASTM D5151-06), the sampling plan used was "AQL 2.5 inspection level G-1." This implies a specific sample size based on the lot size, but the exact number of gloves tested is not provided.
- Other Physical Tests: For physical and dimensions testing (ASTM-D-6319 and ASTM D-5250), the inspection level was S-2, AQL 2.5. Again, the exact sample size for specific tests is not explicitly stated but is determined by the AQL standard applied to the manufacturing lot.
- Biocompatibility Tests: No specific sample size (e.g., number of test subjects or animals) is mentioned for the Primary Skin Irritation and Dermal Sensitization tests.
- Data Provenance: The manufacturing company is Shandong Haoyu Medical Products Co., Ltd. in Qingzhou, Shandong, China. The testing was conducted by the manufacturer or authorized labs, though the specific location of the testing labs is not provided. The data is from retrospective testing of manufactured glove samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For patient examination gloves, "ground truth" is established by adherence to recognized performance standards (ASTM standards, FDA testing protocols) for physical properties and biocompatibility. There are no "experts" establishing clinical ground truth for a diagnostic outcome like in AI/imaging studies. The "experts" in this context would be the technicians and scientists performing the standardized tests according to documented procedures.
4. Adjudication Method for the Test Set
Not applicable. This device relies on standardized physical and biocompatibility testing, not on human interpretation or adjudication processes like 2+1 or 3+1 consensus commonly used for expert review of medical images or data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC study is relevant for diagnostic or AI-assisted devices where human readers interpret data with or without AI assistance. This device is a physical barrier (glove), so such a study is not relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical product, not a software algorithm.
7. Type of Ground Truth Used
For examination gloves, the "ground truth" is defined by:
- Performance Standards: Adherence to established ASTM standards (D5250-06, D5151-06, D6124-06) for physical properties, dimensions, pinhole integrity, and residual powder.
- Biocompatibility Testing: Results from primary skin irritation and dermal sensitization tests demonstrating non-irritant and non-sensitizing properties. These tests are standardized methods.
8. Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of machine learning. The manufacturing process is controlled and optimized, but there's no data-driven model training involved.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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KI32221
JAN 3 1 2014
510(K) SUMMARY
Page 1 of 3
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 5807.92.
-
- Submitter's Identification:
Shandong Haoyu Medical Products Co., Ltd. No.8. Nanhuan Road. Shaozhuang Industry Park Qingzhou, Shandong, China
- Submitter's Identification:
Contact Person: Shao Le Phone Number: 011-86-536-3840824
Date summary prepared: Jan 22, 2014
2. Name of the Device:
Powder Free Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shijiazhuang Star Plastics Co., Ltd. Powder Free Vinyl Patient Examination Gloves. Clear (K100699)
Tangshan Zhonghong Pulin Food Products Co., Ltd. Class I vinyl patient 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.
5. Standard Description:
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 1. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ. and meets all requirement of ASTM Standard D5250-06.
6. 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.
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- Comparison to Predicate Devices on Indication for Use: Our 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 Plastics Co., Ltd. (K100699) Powder-Free Vinyl Patient Examination Gloves.
Discussion of Non-Clinical Test Performed for Determination of Substantial 8. Equivalence are as Follows:
The standards used for Shandony Haoyu Medical Products, Co. Ltd. Lloves product are based on ASTM-D-6319 and ASTM D-5250. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 2.5.
The FDA 1000 ml Water Fill Test based on ASTM-D5151-06 was also conducted samplings of AQL 2.5 inspection level G-1. meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primarv 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).
9. Sterilization
There is no specific device for non-sterile examination gloves. Hand hygiene by rubbing with an alcohol-based hand rub or by washing with soup and water should be performed when appropriate.
10. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
l l. Conclusions:
Our Powder-Free Vinyl 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. and are substantially equivalent in all technological characteristics. including tensile strength. ultimate elongations size. thickness. residual powder and pinhole to predicate devices. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
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Page 3 of 3
| Proposed Device | Predicate Device(K022091) | Predicate Device (K100699) | |
|---|---|---|---|
| Description | Powder Free VinylPatient ExaminationGloves | Class I vinyl patientexamination gloves,powder-free(Tangshan ZhonghongPulin Food ProductsCo., Ltd ) | Powder Free Vinyl PatientExamination Gloves, Clear(Shijiazhuang Star PlasticCo., Ltd) |
| Indication for Use | Disposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontamination betweenpatient and examiner | Substantially equivalent | Substantially equivalent |
| Basic Design | A garment covering thehand and wrist area.Have separate openingsfor each finger and thethumb. | Substantially equivalent | Substantially equivalent |
| Materials Used | Poly Vinyl Chloride | Same | Same |
| Single Use | Yes | Yes | Yes |
| Size | S.M.L,XL | S,M,L,XL | Information Unavailable |
| Sterile | Not sterile | Not sterile | Not sterile |
| Dimension | Meets ASTM D5150-06 | Meets ASTM D5150-06 | Meets ASTM D5150-06 |
| Physical Property | Meets ASTM D5150-06 | Meets ASTM D5150-06 | Meets ASTM D5150-06 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Meets 21 CFR 800.20 |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Primary Skin Irritation | Not an irritant | Not an irritant | Not an irritant |
| Dermal Sensitization | Not a sensitizer | Not a sensitizer | Not a sensitizer |
| Summary of comparison | Our Powder-Free Vinyl Patient Examination Gloves (subject device) andTangshan Zhonghong Pulin Food Products Co., Ltd Class I vinyl patientexamination gloves, powder-free (K022091) (predicate device), and ShijiazhuangStar Plastic Co Ltd Powder Free Vinyl Patient Examination Gloves. Clear(K100699) (predicate device) are substantially equivalent in all technologicalcharacteristics, including tensile strength, ultimate elongations size, thickness,residual powder and pinhole. |
Side-by-Side Comparison of Intended Use, Design, Material, Physical, Biocompatibility, and Performance Testing
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2014
Shandong Haoyu Company Medical Products Company, Limited C/O Mr. Ray Zhou Official Correspondent Basic Medical Industries, Incorporated 12390 East End Avenue Chino, CA 91710
Re: K132221
Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves . Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: December 30, 2013 Received: January 2, 2014
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.
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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 (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132221
Device Name
Powder Free Vinyl Patient Examination Gloves
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
: [x] Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
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§ 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.