(97 days)
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.
Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) 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 D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.
The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)" by Ever Light Plastic Products Company, Ltd. It details the safety and effectiveness information for the device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are largely based on the ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application and ISO 10993-10 for biocompatibility.
| Characteristic | Standard/Acceptance Criteria | Device Performance (Subject Device) | Result of Comparison (to Predicate) | Conclusion (from Non-Clinical Tests) |
|---|---|---|---|---|
| Material | Vinyl (same as predicate) | Vinyl | Similar | N/A (inherent property) |
| Color | Yellow, White, Blue, Pink (same) | Yellow, White, Blue, Pink | Similar | N/A (inherent property) |
| Tensile Strength (Before aging) | ASTM D5250-06: 11 MPa minimum | 15.2-18.1 MPa | Similar (Predicate: 14.3-17.6 MPa) | Pass |
| Tensile Strength (After aging) | ASTM D5250-06: 11 MPa minimum | 14.6-17.4 MPa | Similar (Predicate: 13.3-16.8 MPa) | Pass |
| Ultimate Elongation (Before aging) | ASTM D5250-06: 300% minimum | 390-470% | Similar (Predicate: 380-429%) | Pass |
| Ultimate Elongation (After aging) | ASTM D5250-06: 300% minimum | 360-450% | Similar (Predicate: 370-401%) | Pass |
| Freedom from Pinholes | ASTM D5250-06: G-I, AQL 2.5 | 125 gloves sampled, 0 leaks | Similar (Predicate: 1 leak) | Pass |
| Overall Length (mm) | ASTM D5250-06: 230mm minimum | S: 232-245, M: 233-241, L: 236-243, XL: 234-242 | Similar (Predicate: 245-246mm) | Pass |
| Width (mm) | ASTM D5250-06: S:85±5, M:95±5, L:105±5, XL:115±5 | S: 87-88, M: 97-98, L: 107-108, XL: 118-119 | Similar (Predicate: S/86, M/96, L/106, XL/116) | Pass |
| Palm Thickness (mm) | ASTM D5250-06: 0.08mm minimum | 0.08mm | Similar (Predicate: 0.08-0.10mm) | Pass |
| Finger Thickness (mm) | ASTM D5250-06: 0.05mm minimum | 0.10-0.12mm | Similar (Predicate: 0.10-0.11mm) | Pass |
| Residual Powder | ASTM D5250-06: Not more than 2mg/glove | 0.16mg/glove | Similar (Predicate: 0.9mg/glove) | Pass |
| Primary Skin Irritation | ISO 10993-10: Not an irritant | Not an irritant | Similar (Predicate: Not an irritant) | Pass |
| Dermal Sensitization | ISO 10993-10: Not an irritant | Not an irritant | Similar (Predicate: Not an irritant) | Pass |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the total sample size for the "test set" in a sense that would be typically used for a machine learning model. Instead, it refers to specific sample sizes for particular physical tests:
- Pinhole Test: 125 gloves sampled (for both subject and predicate device performance comparison, and also for the actual testing results).
- Residual Powder: N=5 gloves.
- Other Physical Property Tests (Tensile Strength, Elongation, Dimensions): The inspection level for these tests is S-2, AQL 4.0. While this specifies the sampling plan, the exact number of units sampled for each lot/test is not explicitly given as a single number but is determined by the AQL (Acceptance Quality Limit) table itself.
Data Provenance: The document explicitly states the manufacturer's location as Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000. This indicates the country of origin of the data is China. The studies described are non-clinical (laboratory testing of physical and chemical properties) and appear to be prospective, performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and submission. This is a medical device for which physical characteristics and biocompatibility are tested against established standards (ASTM, ISO). There are no "experts" establishing a "ground truth" in the way one would for diagnostic imaging or a qualitative assessment. The "ground truth" is the objective measurement of the device's properties against predefined quantitative and qualitative standards.
4. Adjudication Method for the Test Set
This information is not applicable. Since the evaluation is against objective, standardized measurements and criteria (e.g., MPa for tensile strength, % for elongation, AQL for pinholes), there's no need for an adjudication method by experts to resolve disagreements. The results are quantitative measurements or qualitative assessments against a defined standard (e.g., "not an irritant").
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. The device is an examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an examination glove, not an algorithm or software. Therefore, standalone algorithm performance is irrelevant.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established consensus standards and objective measurements:
- ASTM D5250-06 (Reapproved 2011) for physical properties (tensile strength, elongation, pinholes, dimensions, residual powder).
- ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).
These standards represent a regulatory and scientific consensus on acceptable performance for medical examination gloves.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/ML device that requires a "training set." The device performance is assessed through direct physical and biocompatibility testing against predefined standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above. There is no training set for this type of medical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Ever Light Plastic Products Company, Ltd. C/O Ms. Kathy Liu Project Manager Hongray USA Medical Products, Inc. 3973 Schaefer Avenue Chino, CA 91710
Re: K142570
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 22, 2014 Received: October 28, 2014
Dear Ms. 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. 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.
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Page 2 - Ms. Liu
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K142570
Device Name
Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR $807.92.
The assigned 510(K) number is:
1. Owner's Identification :
Mr. Zhang Litao Ever Light Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Tel: 86-311-83601854 Fax: 86-311-83616934
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: September 9, 2014
2. Name of the Device:
Trade Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) 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:
Hongze Plastic Technology Co., Ltd. Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) (K101135)
4. Device Description:
Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) 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 D5250-06
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Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
(Reapproved 2011) 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 and Substantial Equivalence:
Ever Light Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) is substantially equivalent in safety and effectiveness to the Hongze Plastic Technology Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) (K 101135). The subject device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.
And the properties between the subject device and the predicate device are compared in the following table:
| Characteristics | Standard | Device Performance | Result ofcomparison | |
|---|---|---|---|---|
| Predicate device | Subject Device | |||
| Product Code | / | LYZ | LYZ | Similar |
| Intended Use | / | Predicate device isdisposable non-sterile deviceintended for medicalpurpose that is wornon the examiner'shand or finger topreventcontaminationbetween patient andexaminer. | Subject device isdisposable non-sterile deviceintended for medicalpurpose that is wornon the examiner'shand or finger topreventcontaminationbetween patient andexaminer. | Similar |
| Labeling | / | There are no speciallabeling claims anddo not claim glovesas hypoallergenic onlabels. | There are no speciallabeling claims anddo not claim glovesas hypoallergenic onlabels. | Similar |
| Device Materials | / | Vinyl | Vinyl | Similar |
| Color | / | Yellow White BluePink | Yellow White BluePink | Similar |
| Device tolerances and specifications & Performance Data: | ||||
| Characteristics | Standard | Device Performance | Result ofcomparison | |
| Tensile strength:before and afteraging | ASTMD 5250-06(2011) | Before aging:14.3-17.6MPaAfter aging:13.3-16.8Mpa | Before aging:15.2-18.1MpaAfter aging:14.6-17.4Mpa | Similar |
| Ultimateelongation:before and afteraging | ASTMD 5250-06(2011) | Before aging:380-429%After aging:370-401% | Before aging:390-470%After aging:360-450% | Similar |
| Freedom frompinholes | ASTMD 5250-06(2011) | G-I, AQL2.5125 glove sampledand 1 piece leaks | G-I, AQL2.5125 glove sampledand 0 piece leaks | Similar |
| Dimensions:Overalllength,Width, PalmandFingerthickness | ASTMD 5250-06(2011) | Length:245-246mmWidth: S/86, M/96,L/106, XL/116Palm Thickness:0.08-0.10mmFinger Thickness:0.10-0.11mm | Length:232-245mmWidth: S/87, M/97,L/107, XL/118Palm Thickness:0.08-0.10mmFinger Thickness:0.10-0.12mm | Similar |
| Residual powder | ASTMD 5250-06(2011) | 0.9mg/glove | 0.16 mg/glove | Similar |
| Biocompatibility | ||||
| Primaryskinirritation test | ISO10993-10 | Under conditions ofthe study, not anirritant | Under conditions ofthe study, not anirritant | Similar |
| Dermalsensitizationassay | ISO10993-10 | Under conditions ofthe study, not anirritant | Under conditions ofthe study, not anirritant | Similar |
| IndicationsForUse | / | Predicate device isdisposable non-sterile deviceintended formedical purposethat is worn on theexaminer's hand orfinger to preventcontamination | Subject device isdisposable non-steriledevice intended formedical purpose thatis worn on theexaminer's hand orfinger to preventcontaminationbetween patient and | Similar |
| Characteristics | Standard | Device Performance | Result of comparison | |
| Predicate device | Subject Device | |||
| between patient and examiner. | examiner. |
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Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
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Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
Ever Light Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D5250-06(2011), biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as Follows:
| Testing Items | FDA-recognizedStandardRequirements | InspectionLevel and AQL | Actual TestingResults | Conclusion |
|---|---|---|---|---|
| OverallLength(mm) | 230 for all sizesminimum | S-2, AQL4.0 | S: 232-245mmM:233-241mmL:236-243mmXL: 234-242mm | Pass |
| Width(mm) | S: 85±5M: 95±5L: 105±5XL: 115±5 | S-2, AQL4.0 | 87-88 mm97-98 mm107-108 mm118-119 mm | Pass |
| PalmThickness(mm) | 0.08mmminimum | S-2, AQL4.0 | 0.08mm | Pass |
| FingerThickness(mm) | 0.05mmminimum | S-2, AQL4.0 | 0.10-0.12mm | Pass |
| Tensile Strength (Mpa) | ||||
| Before aging | 11Mpa minimum | S-2, AQL4.0 | 15.2-18.1Mpa | Pass |
| After aging | 11Mpa minimum | S-2, AQL4.0 | 14.6-17.4Mpa | Pass |
| Ultimate Elongation (%) | ||||
| Before aging | 300% minimum | S-2, AQL4.0 | 390-470% | Pass |
| After aging | 300% minimum | S-2, AQL4.0 | 360-450% | Pass |
| Pinhole | 2.5 | G-I | 125 glove sampledand 0 piece leaks,meet AQL2.5 | Pass |
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Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
| requirements | ||||
|---|---|---|---|---|
| ResidualPowder | Not more than2mg per glove | N=5 | 0.16mg | Pass |
| (a) PrimarySkin IrritationTest | Under conditions of the study, notan irritant | Under conditions of the study, notan irritant | ||
| (b) DermalSensitizationStudy | Under conditions of the study, notan irritant | Under conditions of the study, notan irritant |
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim. There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing.
9. Labeling:
We do not claim our gloves as hypoallergenic on our labels.
10. Conclusions:
Ever Light Plastic Products Co., Ltd's Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) conform fully to ASTM D 5250-06 (2011) standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe, as effective, and performs as well as the legally marketed predicate 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.