(88 days)
Powder Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves Are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application.
The provided document describes the acceptance criteria and performance data for Powder Free Vinyl Patient Examination Gloves (K211177). This is a medical device, and the data provided relates to its physical performance and biocompatibility, not an AI/ML-based diagnostic or imaging device. Therefore, many of the requested fields (such as sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone algorithm performance, and ground truth types related to AI/ML) are not applicable (N/A) for this type of medical device submission.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard / Acceptance Criteria | Device Performance | Result |
|---|---|---|---|
| Physical Properties (ASTM D 5250-19) | |||
| Overall Length (mm) | 230 mm for all sizes minimum | S: 235-241mm; M: 233-240mm; L: 234-241mm; XL: 236-242mm | Meets |
| Width (mm) | S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | S: 86-88 mm; M: 96-98 mm; L: 106-108 mm; XL: 116-118 mm | Meets |
| Palm Thickness (mm) | 0.08mm minimum | 0.08mm | Meets |
| Finger Thickness (mm) | 0.08mm minimum | 0.08-0.10mm | Meets |
| Tensile Strength (Mpa) Before aging | 11Mpa minimum | 13.0-16.1Mpa | Meets |
| Tensile Strength (Mpa) After aging | 11Mpa minimum | 13.0-15.8Mpa | Meets |
| Ultimate Elongation (%) Before aging | 300% minimum | 310-410% | Meets |
| Ultimate Elongation (%) After aging | 300% minimum | 310-400% | Meets |
| Pinhole (Freedom from) | ASTM D 5250-19, ASTM D5151-19, 21CFR800.20 G-I, AQL2.5 | 125 gloves sampled and 1 piece leaks (Meets AQL2.5 for G-I inspection level) | Meets |
| Residual Powder | Not more than 2mg per glove | 0.35-0.73mg | Meets |
| Biocompatibility | |||
| Primary Skin Irritation Test | ISO 10993-10: Not an irritant | Under conditions of the study, not an irritant | Meets |
| Dermal Sensitization Assay | ISO 10993-10: Not an irritant | Under conditions of the study, not an irritant | Meets |
| Cytotoxicity Test | ISO 10993-5: No cytotoxic potential | Under the conditions of this study, no cytotoxic potential | Meets |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Pinhole Test: 125 gloves were sampled.
- Other Physical and Biocompatibility Tests: Sample sizes are not explicitly stated for all tests but are implied by the standards referenced (e.g., "N=5" for residual powder).
- Data Provenance: The manufacturer is Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. located in Shijiazhuang City, Hebei Province, China. The testing was conducted to meet international and US standards (ASTM, ISO, CFR). Specific country of origin for data collection for these non-clinical tests is not detailed beyond the manufacturer's location, but the tests generally follow standardized laboratory protocols rather than clinical data collection. This would be considered prospective testing against established specifications, not retrospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is not relevant for the type of device and testing performed. The "ground truth" for these tests is defined by the objective physical and chemical properties measured against recognized industry standards (ASTM, ISO). No expert clinical assessment of "ground truth" is involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical studies or expert evaluations, which is not applicable here. The tests are objective measurements based on specified standard methods.
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
- N/A. This is a physical non-diagnostic product (gloves). MRMC studies are for evaluating diagnostic tools involving human interpretation, often in conjunction with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device does not have an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" is defined by established engineering and material science standards and specifications (e.g., ASTM D5250-19, ISO 10993-10, ISO 10993-5, ASTM D6124-06, ASTM D5151-19). These standards provide objective, measurable criteria for acceptable performance and biocompatibility.
8. The sample size for the training set
- N/A. This is a physical non-diagnostic product. There is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- N/A. This is a physical non-diagnostic product. No AI/ML training set or associated ground truth establishment method is applicable.
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July 17, 2021
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K211177
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: April 14, 2021 Received: April 20, 2021
Dear Kathy Liu:
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,
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) K211177
Device Name
Powder Free Vinyl Patient Examination Gloves
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand 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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Xinye Industrial Zone, Wangtong Village, Wancheng Town, Gaoyi County, Shijiazhuang City, Hebei Province, 051330 China
Product: Powder Free Vinyl Patient Examination Gloves
510(K) SUMMARY
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR $807.92.
The assigned 510(K) number is: K211177 Date Prepared: July 16, 2021
1. Owner's Identification:
Mr. Lv Zhanmin Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. Xinye Industrial Zone, Wangtong Village, Wancheng Town, Gaoyi County, Shijiazhuang City, Hebei Province, 051330 China Tel: 86-311-83610904
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611
2. Name of the Device:
Trade Name: Powder Free Vinyl Patient Examination Gloves Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LYZ Device Class: Class I
3. Predicate Device Information:
Shanxi Hongjin Plastic Technology Co., Ltd Powder Free Vinyl Patient Examination Gloves- (K180381)
4. Device Description:
Powder Free Vinyl Patient Examination Gloves Are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application.
5. Intended Use of the Device:
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6. Technological Characteristics Comparison:
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd's Powder Free Vinyl Patient Examination Gloves is compared to the Shanxi Hongjin Plastic Technology Co., Ltd's Powder Free Vinyl Patient Examination Gloves- (K180381) in the table below.
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Xinye Industrial Zone, Wangtong Village, Wancheng Town, Gaoyi County,
| Characteristics | Standard | Device Performance | Result of | ||
|---|---|---|---|---|---|
| Predicate device | Subject Device | comparison | |||
| Product Code | / | LYZ | LYZ | Same | |
| Size | / | S, M, L, XL | S, M, L, XL | Same | |
| Intended Use | / | Predicate device isdisposable non-steriledevice intended formedical purpose that isworn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Subject device isdisposable non-steriledevice intended formedical purpose that isworn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Same | |
| Labeling | / | There are no speciallabeling claims and donot claim gloves ashypoallergenic onlabels. | There are no speciallabeling claims and donot claim gloves ashypoallergenic onlabels. | Same | |
| Device Materials | / | Vinyl | Vinyl | Same | |
| Color | / | Clear | Clear | Same | |
| Device tolerances and specifications & Performance Data: | |||||
| Tensile strength:beforeandafteraging | ASTM D 5250-19 | 11Mpa minimum | 11Mpa minimum | Same | |
| Ultimate elongation:beforeandafteraging | ASTM D 5250-19 | 300% minimum | 300% minimum | Same | |
| Freedom frompinholes | ASTM D 5250-19 | G-I, AQL2.5 | G-I, AQL2.5 | Same | |
| Dimensions: Overalllength, Width, PalmandFingerthickness | ASTM D 5250-19 | Meets ASTM D 5250-19 | Meets ASTM D 5250-19 | Same | |
| Residual powder | ASTM D 5250-19 | Not more than 2 mgper glove | Not more than 2 mgper glove | Same | |
| Biocompatibility | |||||
| Primary skinirritation test | ISO 10993-10 | Under conditions ofthe study, not anirritant | Under conditions ofthe study, not anirritant | Same | |
| Dermal sensitization | ISO 10993-10 | Under conditions of | Under conditions of | Same | |
| Characteristics | Standard | Device Performance | Result of comparison | ||
| Predicate device | Subject Device | ||||
| assay | the study, not anirritant | the study, not anirritant | |||
| Cytotoxicity Test | ISO 10993-5 | Under the conditionsof this study, nocytotoxic potential | Under the conditionsof this study, nocytotoxic potential | Same |
Product: Powder Free Vinyl Patient Examination Gloves
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Xinye Industrial Zone, Wangtong Village, Wancheng Town, Gaoyi County, Shijiazhuang City, Hebei Province, 051330 China
Product: Powder Free Vinyl Patient Examination Gloves
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd's Powder Free Vinyl Patient Examination Gloves shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D5250-19, biocompatibility requirement and FDA requirements and the labeling claims for the product..
7. Summary of Non-Clinical Tests:
| Characteristics | FDA-recognizedStandard | Inspection Leveland AQL | Performance Results | Conclusion |
|---|---|---|---|---|
| Overall Length(mm) | ASTM D 5250-19230 for all sizesminimum | S-2, AQL4.0 | S: 235-241mmM:233-240mmL:234-241mmXL: 236-242mm | Meets |
| Width (mm)ASTM D 5250-19 | S: 85±5M: 95±5L: 105±5XL: 115±5 | S-2, AQL4.0 | 86-88 mm96-98 mm106-108 mm116-118 mm | Meets |
| Palm Thickness(mm) | 0.08mm minimum | S-2, AQL4.0 | 0.08mm | Meets |
| FingerThickness (mm) | 0.08mm minimum | S-2, AQL4.0 | 0.08-0.10mm | Meets |
| Tensile Strength (Mpa) ASTM D 5250-19 | ||||
| Before aging | 11Mpa minimum | S-2, AQL4.0 | 13.0-16.1Mpa | Meets |
| After aging | 11Mpa minimum | 13.0-15.8Mpa | Meets | |
| Ultimate Elongation (%) | ||||
| Before aging | 300% minimum | S-2, AQL4.0 | 310-410% | Meets |
| After aging | 300% minimum | S-2, AQL4.0 | 310-400% | Meets |
| Pinhole | ASTM D 5250-19ASTM D5151-1921CFR800.20 | G-I, AQL2.5 | 125 glove sampledand 1 piece leaks | Meets |
| Residual Powder | ASTM D 5250-19ASTM D6124-06(Reapproved 2017) | Not more than2mg per gloveN=5 | 0.35-0.73mg | Meets |
| Primary SkinIrritation andSkinSensitization | ISO 10993-10 | / | Under conditions ofthe study, not anirritant | Meets |
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Xinye Industrial Zone, Wangtong Village, Wancheng Town, Gaoyi County, Shijiazhuang City, Hebei Province, 051330 China
Product: Powder Free Vinyl Patient Examination Gloves
| CytotoxicityTest | ISO 10993-5 | / | Under the conditionsof this study, nocytotoxic potential | Meets |
|---|---|---|---|---|
| ---------------------- | ------------- | --- | ------------------------------------------------------------------ | ------- |
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
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ●
- ASTM D5250-19, Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application
Clinical Performance Data 8.
N/A
9. Conclusion:
The conclusions drawn from the nonclinical and clinical tests demonstrate that the subject device, Powder Free Vinyl Patient Examination Gloves (K211177) is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Powder Free Vinyl Patient Examination Gloves (K180381).
§ 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.