(107 days)
Vinyl Exam Gloves 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.
The proposed device is a powder free medical glove. The device is available in transparent. The device meets the requirements of ASTM D5250-19: Standard specification for Poly (vinyl chloride) Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
The provided document describes the acceptance criteria and a study proving the substantial equivalence of Vinyl Exam Gloves (K213019) to a predicate device. This is a 510(k) submission, focusing on non-clinical performance testing rather than clinical trials.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility - Skin Irritation (ISO 10993-10:2010) | Magnusson and Kligman grade shall be less than control group; No significant reaction than the control group | No skin irritation (Under the conditions of the study, not an Irritant) |
| Biocompatibility - Skin Sensitization (ISO 10993-10:2010) | (Implicitly same as irritation, often evaluated together - document states "Magnusson and Kligman grade shall be less than control group") | No skin sensitization (Under the conditions of the study, not a Sensitization) |
| Biocompatibility - Cytotoxicity (ISO 10993-5:2009) | The viability shall be not reduced to less than 70% | No cytotoxic (Under the conditions of the study, the device is non-cytotoxic) |
| Residual Powder (ASTM D6124-06 (Reapproved 2017)) | Less than 2.0mg per glove | Less than 2.0mg |
| Freedom from Holes (ASTM D5151-06 (Reapproved 2015)) | Do not show droplet, stream, or other type of water leakage | No leakage |
| Physical Dimensions - Length (ASTM D6319-10 (Reapproved 2015)) | > 230 mm | Larger than 230mm |
| Physical Dimensions - Width (ASTM D6319-10 (Reapproved 2015)) | XS = 75±5mm, S = 85±5mm, M = 95±5mm, L = 105±5mm, XL = 115±5mm | XS: within 75±5mm, S: within 85±5mm, M: within 95±5mm, L: within 105±5mm, XL: within 115±5mm (Note: Table 1 uses ASTM D5250-19 and lists width for XL as 105±5mm, but Table 2 uses D6319-10 and lists width for XL as 115±5mm. Assuming D6319-10 is the primary for this test type in T2 and the data aligns with it). |
| Physical Dimensions - Thickness (Finger & Palm) (ASTM D6319-10 (Reapproved 2015)) | All Sizes ≥ 0.08 mm | Larger than 0.08mm |
| Physical Properties - Tensile Strength (Before Aging) (ASTM 412-16) | 11MPa min | Larger than 11Mpa |
| Physical Properties - Ultimate Elongation (Before Aging) (ASTM 412-16) | 300% min | Larger than 300% |
| Physical Properties - Tensile Strength (After Aging) (ASTM 412-16) | 11MPa min | (Implied as "Same" in Table 1; Data not explicitly repeated in Table 2 for aged properties, but stated as meeting requirements for "Larger than 11Mpa and 300%") |
| Physical Properties - Ultimate Elongation (After Aging) (ASTM 412-16) | 300% min | (Implied as "Same" in Table 1; Data not explicitly repeated in Table 2 for aged properties, but stated as meeting requirements for "Larger than 11Mpa and 300%") |
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 specify the exact sample sizes for each non-clinical test (e.g., how many gloves were tested for holes, dimensions, etc.). It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
- Sample Size: Not explicitly stated for specific tests beyond what is implicit in the standard (e.g., ASTM standards typically define sample sizes).
- Data Provenance (Country of Origin): Not explicitly stated, though the manufacturer (Hebei Astro Medical Supply Co., Ltd) is based in China. The testing labs are not identified.
- Retrospective or Prospective: This distinction is not applicable to non-clinical bench testing. These are controlled performance tests conducted on representative samples of the manufactured device.
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)
This information is not applicable to this type of submission. For medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM, ISO) which define objective, measurable physical and biocompatibility properties. There are no human experts establishing a subjective "ground truth" for these tests in the same way, for instance, a radiologist would read an X-ray. The "experts" are the lab technicians and scientists performing the standardized tests according to defined protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation studies where there is subjective assessment by multiple human readers. For standardized non-clinical performance and biocompatibility tests, the results are objectively measured against established criteria.
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. MRMC studies are specific to AI/CAD systems that assist human readers in interpreting medical images. This submission is for medical gloves, which do not involve human interpretation of images or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is defined by the acceptance criteria specified in recognized industry standards (ASTM D5250-19, ASTM D5151-19, ASTM D3767-03 (2020), ASTM D412-16, ASTM D6124-06 (Reapproved 2017), ISO 10993-10:2010, ISO 10993-5:2009, ASTM D6319-10). These standards provide objective, measurable parameters for physical properties (dimensions, tensile strength, elongation, freedom from holes, powder residue) and biological safety (irritation, sensitization, cytotoxicity).
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML device that requires a training set.
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January 5, 2022
Hebei Astro Medical Supply Co., Ltd Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K213019
Trade/Device Name: Vinyl Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: November 26, 2021 Received: December 8, 2021
Dear Diana Hong:
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 mediation-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 Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213019
Device Name Vinyl Exam Gloves
Indications for Use (Describe)
Vinyl Exam Gloves 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.
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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K213019
1. Date of Preparation: 01/03/2022
2. Sponsor Identification
Hebei Astro Medical Supply Co., Ltd
East of Xiaoxixian, West of Jingsan Street, South of Weiwu Road, North of Weiqi Road, Jinzhou Economic Development Zone, Hebei Province, P.R.China, 052260
Establishment Registration Number: 3015537296
Contact Person: Ning Zheng Position: General Manager Tel: +86-18617965639 Fax: +86-311-85125615 Email: erin@wallyplastic.net
3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-2281-5850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Vinyl Exam Gloves Common Name: Examination Vinyl Gloves
Regulatory Information
Classification Name: Vinyl Patient Examination Glove Classification: I; Product Code: LYZ; Regulation Number: 21CFR 880.6250 Review Panel: General Hospital;
Indication for Use:
Vinyl Exam Gloves 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.
Device Description
The proposed device is a powder free medical glove. The device is available in transparent. The device meets the requirements of ASTM D5250-19: Standard specification for Poly (vinyl chloride) Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
ડ. Identification of Predicate Device
510(k) Number: K210799 Product Name: Powder Free Vinyl Patient Examination Glove
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ASTM D5250-19 Standard specification for Poly (vinyl chloride) Gloves for Medical Application
-
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
-
ASTM D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
-
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
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-
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
-
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 ;
- Summary of Technological characteristics 7.
| Table 1 Comparison of Technology Characteristics | ||||
|---|---|---|---|---|
| ITEM | Proposed DeviceK213019 | Predicate DeviceK210799 | Remark | |
| Product Code | LYZ | LYZ | Same | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | |
| Class | I | I | Same | |
| Indication for use | Vinyl Exam Gloves is a disposabledevice intended for medical purposesthat is worn on the examiner's handor finger to prevent contaminationbetween patient and examiner. | The Powder Free PatientExamination Glove is a disposabledevice intended for medical purposesthat is worn on the examiner's handor finger to prevent contaminationbetween patient and examiner. | Same | |
| Material | Vinyl | Vinyl | Same | |
| Color | Clear | Clear | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Single-use | Yes | Yes | Same | |
| Size | XS, S, M, L, XL | XS, S, M, L, XL | Same | |
| Dimensions(ASTM D5250-19) | Width | |||
| XS | $75 \pm 5mm$ | XS | $75 \pm 5mm$ | |
| S | $85 \pm 5mm$ | S | $85 \pm 5mm$ | |
| M | $95 \pm 5mm$ | M | $95 \pm 5mm$ | |
| L | $105 \pm 5mm$ | L | $105 \pm 5mm$ | |
| Length | Same | |||
| XS | 230mm min | XS | 230mm min | |
| S | 230mm min | S | 230mm min | |
| M | 230mm min | M | 230mm min | |
| L | 230mm min | L | 230mm min | |
| XL | 230mm min | XL | 230mm min | |
| Thickness |
Table 1 Comparison of Technology Characteristics
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| Palm | 0.08mm min | Palm | 0.08mm min | |||
|---|---|---|---|---|---|---|
| Finger | 0.08mm min | Finger | 0.08mm min | |||
| Before Aging | ||||||
| Physical Properties(ASTM D5250-19and ASTMD412-16) | Tensile Strength | 11MPa min | Tensile Strength | 11MPa min | Same | |
| Ultimate Elongation | 300% min | Ultimate Elongation | 300% min | |||
| After Aging | ||||||
| Tensile Strength | 11MPa min | Tensile Strength | 11MPa min | |||
| Ultimate Elongation | 300% min | Ultimate Elongation | 300% min | |||
| Power free residue(ASTM D6124-06) | Less than 2mg per glove | Less than 2mg per glove | Same | |||
| Freedom fromHoles (ASTMD5151-19) | No water leakage occurs. | No water leakage occurs. | Same | |||
| Biocompatibility | ||||||
| Skin Irritation | Under the conditions of the study, not an Irritant | Under the conditions of the study, not an Irritant | ||||
| Sensitization | Under the conditions of the study, not a Sensitization | Under the conditions of the study, not a Sensitization | Same | |||
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic. | Under the conditions of the study, the device is non-cytotoxic. |
8. 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.
| No. | Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Test Results |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization | Evaluated for the potential to cause delayed dermal contact sensitization and skin irritation | Magnusson and Kligman grade shall be less than control groupNo significant reaction than the control group | No skin sensitizationNo skin irritation |
| 2 | ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity | Evaluated for the potential cytotoxicity | The viability shall be not reduced to less than 70% | No cytotoxic |
| 3 | ASTM D6124-06 (Reapproved | Evaluate the | Less than 2.0mg | Less than 2.0mg |
Table 2. Summary of Non-Clinical Performance Testing
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| 2017), Standard Test Method forResidual Powder on MedicalGloves | residue powder | |||
|---|---|---|---|---|
| 4 | ASTM D5151-06(Reapproved2015), Standard Test Method forDetection of Holes in MedicalGloves. | Detection theholes that allowwater leakage | Do not show droplet,stream or other type ofwater leakage | No leakage |
| 5 | ASTM D6319-10 (Reapproved2015), Standard Specification forNitrile Examination Gloves forMedical Application. | Evaluate theglove physicaldimension | Length: > 230 mmWidth (±5mm)XS = 75mmS = 85mmM = 95mmL = 105mmXL = 115mmThickness at Finger(mm)All Sizes ≥ 0.08 mmThickness at PalmAll Sizes ≥ 0.08 mm | LengthLarger than 230mmWidthXS: within 75±5mmS: within 85±5mmM: within 95±5mmL: within 105±5mmXL: within 115±5mmThicknessLarger than 0.08mm |
| 6 | ASTM 412-16 Standard TestMethods for Vulcanized Rubberand ThermoplasticElastomers-Tension | Evaluate thephysicalrequirement | Tensile strength: 11MpaUltimate elongation:300% | Larger than 11Mpa and300% |
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device K210799.
§ 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.