(58 days)
The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vinyl Patient Examination Gloves (K182115):
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a "table of acceptance criteria" in the typical sense for a medical device's performance in a diagnostic or therapeutic context. Instead, it compares the proposed device's characteristics and performance against a predicate device and relevant ASTM/ISO standards. Here's a table summarizing the key performance aspects that act as de facto acceptance criteria by demonstrating equivalence to the predicate and compliance with standards:
| Acceptance Criterion (via Predicate Equivalence & Standards Compliance) | Reported Device Performance (Proposed Device) |
|---|---|
| Dimension: Length (min) | 230mm (XS), 230mm (S), 235mm (M), 245mm (L), 245mm (XL) |
| Dimension: Width (±5mm) | 80mm (XS), 85mm (S), 95mm (M), 105mm (L), 115mm (XL) |
| Dimension: Finger Thickness (min) | 0.05mm |
| Dimension: Palm Thickness (min) | 0.08mm |
| Physical Properties: Before Aging Tensile Strength (min) | 15MPa |
| Physical Properties: Before Aging Ultimate Elongation (min) | 380% |
| Physical Properties: After Aging Tensile Strength (min) | 15MPa |
| Physical Properties: After Aging Ultimate Elongation (min) | 380% |
| Physical Properties: Compliance with ASTM D5250 | Complies with ASTM D5250 |
| Freedom from Holes: ASTM D5151 AQL | AQL=1.5 (Meets ASTM D5151) |
| Powder Content: Compliance with ASTM D6124 | 0.49 mg per glove (Meets ASTM D6124 requirements) |
| Biocompatibility: Irritation (ISO 10993-10) | Not an irritant under study conditions |
| Biocompatibility: Sensitization (ISO 10993-10) | Not a sensitizer under study conditions |
| Biocompatibility: Cytotoxicity (ISO 10993-5) | Did not show potential toxicity to L-929 cells |
| Label and Labeling: FDA's Requirement | Meets FDA's Requirement |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for tensile strength, or freedom from holes). It refers to compliance with standards like ASTM D5151 for Freedom from Holes, which would dictate sampling plans. The data provenance is retrospective testing of the manufactured medical device components. The company, Ping An Medical Products Co., Ltd., is located in China (Jiangxi Province), indicating the country of origin for the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The "ground truth" for this device (patient examination gloves) is established through adherence to recognized international and national standards (ASTM, ISO) for physical properties, biocompatibility, and freedom from defects. There isn't a "ground truth" in the diagnostic sense that requires expert consensus on a clinical condition.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to determine a true diagnosis or outcome. For a physical product like examination gloves, compliance with precise measurement and testing standards is the primary method of evaluation.
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:
This information is not applicable and not provided. This device is a medical glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable and not provided. This device is a medical glove, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device relies on:
- Compliance with established industry standards: ASTM D5250, ASTM D5151, ASTM D6124 for physical properties and defect levels.
- Biological safety standards: ISO 10993-10 (irritation, sensitization) and ISO 10993-5 (cytotoxicity) for biocompatibility.
- Comparison to a legally marketed predicate device (K163168) for demonstrating substantial equivalence.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This device is a physical product, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided. As mentioned, there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 3, 2018
Ping An Medical Products Co., Ltd. % Boyle Wang Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, 200120 Cn
Re: K182115
Trade/Device Name: Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: July 20, 2018 Received: August 6, 2018
Dear Boyle Wang:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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) K182115
Device Name Vinyl patient examination glove
Indications for Use (Describe)
The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands 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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510(k) Summary K182115
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Ping An Medical Products Co., Ltd. Address: Zhe Ji road, High-tech Industrial Zone of Hukou County, Jiu jiang City, Jiangxi Province China, 332000 Phone Number: Contact: Mr. Fu Dong Zhang Date of Preparation: 9/25/2018
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel:+86-18930777676, Fax:+86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
- Trade name: Vinyl Patient Examination Gloves
Common name: Patient Examination Gloves
Classification name: Non-powdered Patient Examination Glove
510(k) number: K182115
Model(s): XS, S, M, L, XL
3.0 Classification -
Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
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4.0 Predicate device information
Hebei Hongtai Plastic Products Company Limited Manufacturer: Device: Vinyl Patient Examination Gloves (White, Blue, Yellow) 510(k) number: K163168
5.0 Indication for Use
The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.
6.0 Device description
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
7.0 Summary comparing technological characteristics with predicate device
| Item | Proposed device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K182115 | K163168 | |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl PatientExamination Glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hands toprevent contaminationbetween patient andexaminer. | The Vinyl ExaminationGlove (White, Blue, orYellow) is a disposabledevice intended formedical purposes thatis worn on theexaminer's hands toprevent contaminationbetween patient andexaminer. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single use, powder free,device color, device | Single use, powderfree, device color, | Similar |
Table1-General Comparison
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| name, glove size and | device name, glove size | |
|---|---|---|
| quantity, Vinyl | and quantity, Vinyl | |
| Examination Gloves, | Examination Gloves, | |
| Non-Sterile | Non-Sterile |
| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K163168) | XS | S | M | L | XL | ||
| Length, mm | 230 | 230 | 235 | 245 | 245 | min | |
| Width, mm | 80 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Proposed Device | Designation | Size | Tolerance | ||||
| XS | S | M | XS | S | |||
| Length, mm | 230 | 230 | 235 | 245 | 245 | min | |
| Width, mm | 80 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Remark | SAME |
Table2 Device Dimensions Comparison
Table3 Performance Comparison
| Item | Proposed device | Predicated device | Comparison | |
|---|---|---|---|---|
| Colorant | Clear, Non-Colored | White, Blue, Yellow | Analysis1 | |
| PhysicalProperties | BeforeAgingTensileStrength | 15MPa, min | 15MPa, min | SAME |
| UltimateElongation | 380%min | 380%min | SAME | |
| AfterAgingTensileStrength | 15MPa, min | 15MPa, min | SAME | |
| UltimateElongation | 380%min | 380%min | SAME | |
| Comply with ASTM D5250 | Comply with ASTM D5250 | SAME | ||
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL=1.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | SAME | |
| Powder Content | 0.49 mg per glove | Meet the requirements of ASTM D6124 | SIMILAR |
Analysis1: The proposed device (colorless) has different color to the predicate device (White, Blue, Yellow), but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not affect the safety of proposed device
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| Item | Proposed device | Predicated device | Comparison | |
|---|---|---|---|---|
| Material | Vinyl | Vinyl | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. | / | SIMILAR | |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Table4 Safetv Comparison
8.0 Discussion of non-clinical and clinical test performed
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTMD5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
Clinical testing is not needed for this device.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicated device.
§ 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.