(89 days)
The Disposable Vinyl/Nitrile Blend Medical Examination Gloves is intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. 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 document is a 510(k) premarket notification for "Disposable Vinyl/Nitrile Blend Medical Examination Gloves." It describes non-clinical performance testing to demonstrate substantial equivalence to a predicate device, rather than a study involving an AI/CADe device. Therefore, much of the requested information regarding AI/CADe specific studies (such as MRMC studies, effect size of AI assistance, standalone performance, training set details, and expert ground truth establishment) is not applicable.
Here's the available information relevant to the acceptance criteria and the study (non-clinical testing) that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1 | ISO 10993-5 (Cytotoxicity) | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. (Pass) |
| 2 | ISO 10993-10 (Irritation) | Irritation | Non-irritating | Under the conditions of the study, not an irritant. (Pass) |
| 3 | ISO 10993-10 (Sensitization) | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. (Pass) |
| 4 | ISO 10993-11 (Systemic toxicity) | Systemic toxicity | Non-Systemic toxic | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. (Pass) |
| 5 | ASTM D6124-06 (Powder Content) | Determine the amount of residual powder | Powder residue limit of 2.0 mg per glove | 0.15mg - 0.18 mg /glove (Meets requirements of ASTM D5250 ASTM D6124 - 06(2017) as stated in the "Analysis" section of Table4) |
| 6 | ASTM D5151-06 (Freedom from Holes) | Detection of holes in medical gloves | Samples number: 125 gloves, AQL: 2.5 (ISO 2859), Criterion ≤7 gloves for water leakage | no glove water leakage found (Pass) |
| 7 | ASTM D5250 (Physical Dimensions Test) | Physical Dimensions Test | Length(mm): ≥230; Width(mm): S: 85±5, M: 95±5, L: 105±5, XL: 115±5; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Lot no. 1: S: width: 83-88 mm, Length 231-238 mm (one data 227mm, 1 non-conforming, acceptable); M: width 92-96 mm, Length 233-236 mm; L: width 102-106 mm, Length 246-253 mm; XL: width 111-116 mm, Length 242-245 mm. Thickness: Finger 0.10-0.11 mm, Palm 0.07-0.08 mm. Lot no. 2: S: width: 82-85 mm, Length 232-235 mm; M: width 92-96 mm, Length 232-236 mm; L: width 103-106 mm, Length 243-249 mm; XL: width 111-116 mm, Length 237-243 mm. Thickness: Finger 0.11-0.12 mm, Palm 0.07-0.08 mm. Lot no. 3: S: width: 82-87 mm, M: width 93-96mm, Length 230-239 mm; L: width 103-107mm, Length 243-249 mm; XL: width 112-116 mm, Length 244-249 mm. Thickness: Finger 0.11 mm, Palm 0.07-0.08 mm. (Pass for all) |
| 8 | ASTM D412 (Physical properties) | Physical properties (Before & After Aging) | Before Aging: Tensile Strength: ≥11MPa; Ultimate Elongation: ≥300%. After Aging: Tensile Strength: ≥11MPa; Ultimate Elongation: ≥300%. | Before Aging: Lot 1: 12.7-24 MPa, 300.08-397.467 %; Lot 2: 15.1-25.1 MPa, 300.547-380.29 % (one data 228.080, 1 non-conforming, acceptable); Lot 3: 14.5-23.5 MPa, 303.365-389.716 %. (Pass for all) After Aging: Lot 1: 14.2-22.4 MPa, 301.276-394.245 %; Lot 2: 16.0-23.8 MPa, 300.79-399.170 %; Lot 3: 14.4-23.3 MPa, 307.674-399.758 %. (Pass for all) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the country of origin for the testing data. The company is based in China. The testing appears to be prospective, performed specifically for regulatory submission.
- ISO 10993-5, 10, 11 (Biocompatibility): The sample sizes are not explicitly stated for these tests beyond "conditions of the study" and "model animal" for systemic toxicity.
- ASTM D6124-06 (Powder Content): The sample size per glove for the reported residue is 0.15mg - 0.18 mg /glove, but the number of gloves tested for this average is not specified.
- ASTM D5151-06 (Freedom from Holes): 125 gloves were tested.
- ASTM D5250 (Physical Dimensions Test): Three lots (Lot no. 1, 2, 3) were tested. The specific number of gloves per lot for each size (S, M, L, XL) is not explicitly stated. For "Lot no. 1: Dimensions: S: ... (one data 227mm, the number of non-conforming is 1, acceptable)", this implies individual measurements were taken, but the total sample size isn't clear.
- ASTM D412 (Physical properties): Three lots (Lot 1, 2, 3) were tested. Similar to dimensions, the number of samples per lot for the tensile strength and ultimate elongation tests is not explicitly stated, although it notes "one data" point for Lot 2's ultimate elongation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a medical device (gloves) and the testing involves physical and chemical property assessments, not interpretation by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/CADe study involving human reviewers.
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/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/CADe device. The performance data presented are for the device itself (gloves).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by the specified industry standards (e.g., ISO 10993, ASTM D6124, ASTM D5151, ASTM D5250, ASTM D412). These standards define objective, measurable criteria for the physical and biological properties of patient examination gloves.
8. The sample size for the training set:
Not applicable. This is not an AI/CADe device and therefore does not have a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/CADe 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.
December 11, 2021
Bytech(Dongtai) Co., Ltd. Boyle Wang Manager Shanghai Truthful information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K212899
Trade/Device Name: Disposable Vinyl/Nitrile Blend Medical Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: August 30, 2021 Received: September 13, 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, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212899
Device Name
Disposable Vinyl/Nitrile Blend Medical Examination Gloves
Indications for Use (Describe)
The Disposable Vinyl/Nitrile Blend Medical Examination Gloves is intended for medical purposes that is worn on the examiners 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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K212899 510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Bytech (Dongtai) Co., Ltd. Address: XinYuan Industrial Park,TangYang Town, DongTai City, Jiangsu Province, China Phone Number: Contact: Mr. Wang Cheng Date of Preparation: 2021.08.30
Designated Submission Correspondent
Mr. Boyle Wanq 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 Blend Medical Examination Gloves Common name: Disposable Vinyl/Nitrile Blend Medical Examination Gloves Classification name: Non-powdered Patient Examination Glove Model(s): 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
Tangshan Hongyun Healthcare Products Co.,Ltd. Manufacturer: Device: Disposable Vinyl Nitrile Synthetic Gloves Powder Free 510(k) number: K211262
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5.0 Indication for Use
The Disposable Vinyl/Nitrile Blend Medical Examination Gloves is intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.
6.0 Device description
The subject device is powder free vinyl patient examination gloves. 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.
7.0 Summary comparing technological characteristics with predicate device
| Item | Subject device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K212899 | K211262 | / |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The DisposableVinyl/Nitrile BlendMedical ExaminationGloves is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | The Disposable VinylNitrile Synthetic GlovesPowder Free is adisposable deviceintended for medicalpurposes that is wornon the examiner'shands to preventcontamination betweenpatient 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, devicename, glove size andquantity, VinylExamination Gloves,Non-Sterile | Single use, powderfree, device color,device name, glove sizeand quantity, VinylExamination Gloves,Non-Sterile | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Predicate | Designation | Size | Tolerance |
|---|---|---|---|
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| Device(K211262) | S | M | L | XL | ||
|---|---|---|---|---|---|---|
| Length, mm | 230 | 230 | 230 | 230 | min | |
| Width, mm | 85 | 95 | 105 | 115 | $\pm$ 5 | |
| Thickness, mm: | ||||||
| Finger | 0.05 | min | ||||
| Palm | 0.05 | min | ||||
| Subject Device | Designation | Size | Tolerance | |||
| S | M | L | XL | |||
| Length, mm | 230 | 230 | 230 | 230 | min | |
| Width, mm | 85 | 95 | 105 | 115 | $\pm$ 5 | |
| Thickness, mm: | ||||||
| Finger | 0.05 | min | ||||
| Palm | 0.05 | min | ||||
| Remark | Same |
Table3 Performance Comparison
| Item | Subject device | Predicated device | Comparison | ||
|---|---|---|---|---|---|
| Colorant | Blue | Blue | SAME | ||
| PhysicalProperties | Before Aging | TensileStrength | SAME | 11MPa, min | SAME |
| UltimateElongation | SAME | 300%min | SAME | ||
| AfterAging | TensileStrength | SAME | 11MPa, min | SAME | |
| UltimateElongation | SAME | 300%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=2.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | SAME | ||
| Powder Content | 0.15-0.18 mg per glove | 0.07 mg per glove. Meet the requirements of ASTM D6124 | SIMILAR |
Analysis: The powder content is different with that of the predicate, but they all meet the requirements of ASTM D5250 ASTM D6124 - 06(2017).
Table4 Safety Comparison
| Item | Subject device | Predicated device | Comparison |
|---|---|---|---|
| Material | Vinyl | Vinyl | SAME |
| Biocompatibility | IrritationUnder the conditions of the study, not an irritant | Comply withISO10993-10 | SAME |
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| Sensitization | Under conditions of the study, not a sensitizer. | |||
|---|---|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | SIMILAR | |
| Systemic toxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ISO 10993-11 Third edition 2017-09 | ||
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Analysis: The material of subject device are different with that of the predicate device, but biocompatibility test has been performed on subject device and the test result can meet the requirements of ISO 10993 standards.
8.0 Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
| Table 5 Summary of Non-Clinical Performance Testing | |
|---|---|
| ----------------------------------------------------- | -- |
| No. | Name of the TestMethodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, didnot show potential toxicity toL-929 cells. |
| 2 | ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study,not an irritant. Pass |
| 3 | ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, nota sensitizer. Pass |
| 4 | ISO 10993-11 | Systemic toxicity | Non-Systemic toxic | Under the conditions of the study,the device does not elicit asystemic toxicity response in themodel animal. Pass |
| 5 | ASTM D6124-06 | This standard isdesigned todetermine theamount ofresidualpowder (orfilter-retainedmass) found | powder residue limit of2.0 mg | 0.15mg -0.18 mg /glove |
| 6 | ASTMD5151-06(Reapproved2015) | on medical glovesThis test methodcovers thedetection of holesinmedical gloves. | Samples number: 125 glovesAQL: 2.5 (ISO 2859)Criterion ≤7 glovesfor water leakage | no glove water leakage found |
| 7 | ASTM D5250 | PhysicalDimensions Test | Sterility: no needFreedom from holes:pl. Refer to No. 5 intable 5Dimensions:Length(mm):≥230;Width(mm):S: 85±5;M: 95±5;L: 105±5;XL: 115±5;Thickness (mm):Finger: ≥0.05 Palm:≥0.05 | N.A.Please refer to No. 5 in table 5Lot no. 1:Dimensions:S: width: 83-88 mmLength 231-238 mm (one data227mm, the number ofnon-conforming is 1, acceptable)M: width 92-96 mmLength 233-236 mmL: width 102-106 mmLength 246-253 mmXL: width 111-116 mmLength 242-245 mmThickness:Finger 0.10-0.11 mmPalm 0.07-0.08 mmLot no.:2Dimensions:S: width: 82-85 mmLength 232-235 mmM: width 92-96 mmLength 232-236 mmL: width 103-106 mmLength 243-249 mmXL: width 111-116 mmLength 237-243 mmThickness:Finger 0.11-0.12 mmPalm 0.07-0.08 mmLot no.:3Dimensions:S: width: 82-87 mm |
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| M: width 93-96mmLength 230-239 mm | ||||||
|---|---|---|---|---|---|---|
| L: width 103-107mmLength 243-249 mm | ||||||
| XL: width 112-116 mmLength 244-249 mm | ||||||
| Thickness: | ||||||
| Finger 0.11 mm | ||||||
| Palm 0.07-0.08 mm | ||||||
| Pass | ||||||
| 8 | ASTM D412 | Physical properties | BeforAging | TensileStrength | ≥11MPa | Lot 1: 12.7-24 MPaLot 2: 15.1-25.1 MPaLot 3: 14.5-23.5 MPaPass |
| UltimateElongation | ≥300% | Lot 1: 300.08-397.467 %Lot 2: 300.547-380.29 %(one data 228.080, the numberof non-conforming is 1,acceptable)Lot 3: 303.365-389.716 %Pass | ||||
| AfterAging | TensileStrength | ≥11MPa | Lot 1: 14.2-22.4 MPaLot 2: 16.0-23.8 MPaLot 3: 14.4-23.3 MPaPass | |||
| UltimateElongation | ≥300% | Lot 1: 301.276-394.245 %Lot 2: 300.79-399.170 %Lot 3: 307.674-399.758 %Pass |
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10.0 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 legally marketed 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.