(97 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. During the production process, about 1% ~ 3% nitrile is added to the ingrove the tensile strength and ultimate elongation of the glove. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text is a 510(k) Summary for a medical device (Disposable Synthetic Vinyl Nitrile Examination Glove). It outlines acceptance criteria and test results for various non-clinical tests. Since the device is not an AI/ML powered device, the questions related to AI/ML powered devices are not applicable.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length(mm): $\ge$ 230;Width(mm):XS: 75 $\pm$ 5;S: 85 $\pm$ 5;M: 95 $\pm$ 5;L: 105 $\pm$ 5;XL: 115 $\pm$ 5;Thickness (mm):Finger: $\ge$ 0.08Palm: $\ge$ 0.08 | Length: >230/ PassWidth:XS: 78-80/ PassS: 85-86/PassM: 95-96/PassL: 105-106/PassXL: 115-116/PassFinger Thickness:XS: 0.11-0.12/PassS:0.11-0.12/PassM:0.11-0.13/PassL:0.11-0.13/PassXL:0.11-0.13/PassPalm Thickness:XS:0.08-0.09/PassS:0.08-0.09/PassM:0.08-0.09/PassL:0.08-0.09/PassXL:0.08-0.09/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL=2.5 | XS:0/125;S:1/125;M:3/125; L:2/125;XL:2/125 leaks / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS:0.89 mg/Pass; S: 0.92 mg/Pass; M: 0.91 mg/Pass; L: 0.92 mg/Pass; XL: 0.95 mg/Pass; |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: $\ge$ 11MPaUltimate Elongation: $\ge$ 300% | Not explicitly reported as specific values for the subject device in the table, but the comparison section notes they "meet the requirements of ASTM D5250". |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: $\ge$ 11MPaUltimate Elongation: $\ge$ 300% | Not explicitly reported as specific values for the subject device in the table, but the comparison section notes they "meet the requirements of ASTM D5250". |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells./ Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
2. Sample size used for the test set and the data provenance
- ASTM D5151 (Watertightness): For detection of holes, the sample size was 125 gloves per size (XS, S, M, L, XL), with results like "XS:0/125; S:1/125; M:3/125; L:2/125; XL:2/125 leaks".
- ASTM D6124 (Powder Content): The sample size appears to be one glove per size for the reported powder content (e.g., "XS:0.89 mg/Pass").
- For other tests (ASTM D5250 Physical Dimensions, ASTM D412 Physical Properties, ISO 10993-5 Cytotoxicity, ISO 10993-10 Irritation and Sensitization), specific sample sizes are not detailed in the provided summary.
- Data Provenance: The document does not explicitly state the country of origin for the test data or whether it was retrospective or prospective. Given the submitter's address in China, it is likely the testing was conducted there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML powered device, and the tests relate to physical and biological properties, not interpretation by experts.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against defined standards, not requiring adjudication by experts.
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
Not applicable. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on established industry standards and regulatory requirements (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, ISO 10993-10). The "ground truth" is adherence to these specifications as measured by laboratory testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 8, 2021
Jiangsu Cureguard Glove Co., Ltd. % Boyle Wang Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K211354
Trade/Device Name: Disposable Synthetic Vinyl Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: July 21, 2021 Received: July 30, 2021
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 may, 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 aware 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
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray, III. PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211354
Device Name Disposable Vinyl Nitrile Synthetic 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 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 K211354
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Jiangsu Cureguard Glove Co., Ltd. Address: No. 65 Shenzhen Road, The Economic Development Zone, Suqian, Jiangsu, 223800 China Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: 07/21/2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
| Trade name: | Disposable Vinyl Nitrile Synthetic Gloves |
|---|---|
| Common name: | Vinyl Patient Examination Glove |
| Classification name: | Non-powdered Patient Examination Glove |
| Model(s): | XS,S, M, L, XL |
3.0_Classification
Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Zibo Huiying Medical Products, Co. Ltd. Device: Synmax Synthetic Patient Examination Vinyl Gloves,Powder Free,Blue 510(k) number: K153028
5.0 Indication for Use
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7.0 Technological Characteristic ComparisonTable
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free vinyl patient examination gloves. During the production process, about 1% ~ 3% nitrile is added to the ingrove the tensile strength and ultimate elongation of the glove.
The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
| Item | Subject device | Predicatedevice | Comparison |
|---|---|---|---|
| 510(k) number | K211354 | K153028 | / |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner. | 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. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single use, powder free, device color, device name, glove size and quantity, product name, Non-Sterile | Single use, powder free, device color, device name, glove size and quantity, product name, Non-Sterile | Similar |
Table2 Device Dimensions Comparison
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| PredicateDevice(K153028) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Length, mm | Average over 234 on M size | - | |||||
| Width, mm | Average over 96 on M size | - | |||||
| Thickness, mm: | |||||||
| Finger | Average 0.98 | - | |||||
| Palm | Average 0.096 | - | |||||
| Subject Device(K211354) | Designation | XS | S | M | L | XL | Tolerance |
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.08 | min | |||||
| Palm | 0.08 | min | |||||
| Remark | Similar |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250.
| Item | Subject device(K211354) | Predicate device(K153028) | Comparison | |
|---|---|---|---|---|
| Colorant | Blue | Blue | Same | |
| PhysicalProperties | Before AgingTensile Strength | 11MPa, min | Average 16.9MPa | Different |
| Ultimate Elongation | 300%min | Average 550% | Different | |
| After AgingTensile Strength | 11MPa, min | Average 14.4MPa, min | Different | |
| Ultimate Elongation | 300%min | Average 500% | Different | |
| Comply with ASTM D5250 | Comply with ASTM D5250 | Comply with ASTM D5250 | Same | |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Same | |
| Powder Content | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Similar |
Analysis: The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250.
Table4 Safety Comparison
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| Item | Subject device(K211354) | Predicate device(K153028) | Comparison | ||
|---|---|---|---|---|---|
| Material | Poly Vinyl ChloridePolyurethaneNitrileDi-(2-ethylhexyl)Terephthalate(DOTP) | Poly VinylChloridePolyurethaneDiisononylPhthalate (DINP) | SimilarDifferent | ||
| Biocompatibility | Irritation | Under the conditions of thestudy, not an irritant | ComplywithISO10993-10 | Same | |
| Sensitization | Under conditions of thestudy, not a sensitizer. | ||||
| Cytotoxicity | Under conditions of thestudy, did not showpotential toxicity to L-929cells. | / | Similar | ||
| Label and Labeling | Meet FDA's Requirement | Meet FDA'sRequirement |
Analysis: The materials of the subject device are little different with that of the predicate, but they all meet the performance requirements of ASTM D5250.
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
ASTMD5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
| TestMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5250 | PhysicalDimensionsTest | Length(mm): $\geq$ 230; | Length: >230/ Pass |
| Width(mm): | Width: | ||
| XS:75 $\pm$ 5; | XS: 78-80/ Pass | ||
| S: 85 $\pm$ 5; | S: 85-86/Pass | ||
| M: 95 $\pm$ 5; | M: 95-96/Pass | ||
| L: 105 $\pm$ 5; | L: 105-106/Pass |
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| XL: 115±5;Thickness (mm) :Finger: ≥0.08Palm: ≥0.08 | XL: 115-116/PassFinger Thickness:XS: 0.11-0.12/PassS:0.11-0.12/PassM:0.11-0.13/PassL:0.11-0.13/PassXL:0.11-0.13/PassPalm Thickness:XS:0.08-0.09/PassS:0.08-0.09/PassM:0.08-0.09/PassL:0.08-0.09/PassXL:0.08-0.09/Pass | ||
|---|---|---|---|
| ASTM D5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTM D5151AQL 2.5 | XS:0/125;S:1/125;M:3/125;L:2/125;XL:2/125 leaks /Pass |
| ASTM D6124 | PowderContent | Meet the requirements of ASTM D6124< 2.0mg | XS:0.89 mg/Pass;S: 0.92 mg/Pass;M: 0.91 mg/Pass;L: 0.92 mg/Pass;XL: 0.95 mg/Pass; |
| ASTM D412 | Physicalproperties | BeforeAging | |
| TensileStrengthUltimateElongationAfter AgingTensileStrengthUltimateElongation | ≥11MPa≥300%≥11MPa≥300% | ||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of thestudy, did not show potentialtoxicity to L-929 cells./ Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of thestudy, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of thestudy, not a sensitizer./Pass |
9.0 Clinical Test Conclusion
Clinical testing is not needed for this device.
Conclusion 10.0
The conclusions drawn from the nonclinical tests demonstrate that the proposed device,Disposable Vinyl Nitrile Synthetic Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K153028.
§ 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.