(100 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.
Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber 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 describes the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K142409) and seeks to prove its substantial equivalence to a predicate device (K061562). The study conducted is a non-clinical performance study comparing the subject device against the predicate device based on established standards and FDA requirements.
Here's the breakdown of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance:
| Characteristic | Acceptance Criteria (Stated Standard ASTM D5250-06(2011) or other) | Reported Device Performance (Subject Device K142409) | Result of Comparison to Predicate & Acceptance |
|---|---|---|---|
| Material | Vinyl and oil-based liquid Nitrile compound (plasticizer type different) | Vinyl and oil-based liquid Nitrile compound (plasticizer type different) | Similar |
| Color | Blue | Blue | Similar |
| Tensile Strength (Mpa) | |||
| - Before aging | 11 Mpa min | 15.2 Mpa min | Pass (Exceeds standard and similar to predicate) |
| - After aging | 11 Mpa min | 14.6 Mpa min | Pass (Exceeds standard and similar to predicate) |
| Ultimate Elongation (%) | |||
| - Before aging | 300% min | 390% min | Pass (Exceeds standard and similar to predicate) |
| - After aging | 300% min | 360% min | Pass (Exceeds standard and similar to predicate) |
| Freedom from Pinholes | AQL 2.5 (G-I) | AQL 1.5 (G-I) | Pass (Exceeds standard and similar to predicate, lower AQL is better) |
| Overall Length (mm) | 230 for all sizes min (S-2, AQL4.0) | 239 mm (for all sizes) | Pass (Exceeds standard and similar to predicate) |
| Width (mm) | S: 85±5, M: 95±5, L: 105±5, XL: 115±5 (S-2, AQL4.0) | S: 87, M: 97, L: 107, XL: 118 | Pass (Within range and similar to predicate) |
| Palm Thickness (mm) | 0.08 mm min (S-2, AQL4.0) | 0.08 mm | Pass (Meets standard and similar to predicate) |
| Finger Thickness (mm) | 0.05 mm min (S-2, AQL4.0) | 0.10 mm | Pass (Exceeds standard and similar to predicate) |
| Residual Powder | Not more than 2mg per glove (N=5) | Not more than 2mg per glove | Pass (Meets standard and similar to predicate) |
| Primary Skin Irritation Test | Under conditions of the study, not an irritant (ISO 10993-10) | Under conditions of the study, not an irritant | Similar (Pass) |
| Dermal Sensitization Assay | Under conditions of the study, not an irritant (ISO 10993-10) | Under conditions of the study, not an irritant | Similar (Pass) |
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 Test Set: The sample sizes for each test are indicated by the "Inspection Level and AQL" or "N" values.
- For physical dimensions (Overall Length, Width, Palm Thickness, Finger Thickness), Tensile Strength, and Ultimate Elongation: S-2, AQL4.0.
- For Pinhole: G-I, AQL1.5.
- For Residual Powder: N=5 (5 gloves tested).
- For Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The specific number of samples (e.g., animals, human subjects, in-vitro replicates) is not explicitly stated, but the tests were performed "Under conditions of the study".
- Data Provenance: The study was conducted by Grand Work Plastic Products Co., Ltd., which is located in Zanhuang, Hebei, China. The data originates from this manufacturer. It is a prospective study as the tests were performed on the subject device to demonstrate compliance.
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 study is a physical and chemical performance test of a medical device (examination gloves), not an AI/clinical diagnostic device. Therefore, it does not involve experts establishing "ground truth" in the clinical sense (e.g., radiologists, pathologists). The "ground truth" is established by the pre-defined technical standards (e.g., ASTM D5250-06(2011), ISO 10993-10) and FDA requirements. The tests are performed by technicians in a laboratory setting according to specified protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human readers or clinical adjudication. The results are quantitative measurements or qualitative observations against a set standard.
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 a performance study for a physical device (examination gloves), not a comparative effectiveness study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a performance study for a physical device (examination gloves), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this study is based on established industry standards and regulatory requirements. Specifically:
- ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
- ISO 10993-10 for biocompatibility (Primary Skin Irritation and Dermal Sensitization).
- FDA requirements (e.g., for pinhole AQL).
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI study; there is no training set involved.
9. How the ground truth for the training set was established:
Not applicable. There is no training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5,2014
Grand Work Plastic Products Company Limited C/O Ms. Kathy Liu Hongray USA Medical Products Incorporated 3973 Schaefer Avenue Chino, CA 91710
Re: K142409
Trade/Device Name: Vinyl Co-Polymer Powder-free Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 31, 2014 Received: November 5, 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,
Susan Runco, DDS, MA
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) K142409
Device Name
Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Donggao Industrial Zone Zanhuang, Hebei, China 050000
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: K142409
Date Summary Prepared: December 3, 2014
1. Owner's Identification:
Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China 050000 Tel: +86-0311-83980225 Fax: +86-0311-83634221 Contact: Ms. May Jia Position title: Project Manager
2. Name of the Device:
Trade Name: Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital Product Code: LYZ Device Class: Class I
3. Predicate Device Information:
Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K061562)
4. Device Description:
Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber 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.
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.
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Donggao Industrial Zone Zanhuang, Hebei, China 050000
6. Technological Characteristics and Substantial Equivalence:
Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color is substantially equivalent in safety and effectiveness to the Grand Work Plastic Products Co., Ltd. 's Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K 061562). 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 | Device Performance | Result ofcomparison | ||
|---|---|---|---|---|
| Predicate deviceK061562 | Subject DeviceK142409 | |||
| Product Code | LYZ | LYZ | Similar | |
| Indications For Use | Predicate device isdisposable non-steriledevice intended for medicalpurpose that is worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer. | Subject device is disposablenon-sterile device intendedfor medical purpose that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. | Similar | |
| Labeling | It is Patient ExaminationGlove, Disposable, singleuse only and non-sterile | It is Patient ExaminationGlove, Disposable, singleuse only and non-sterile | Similar | |
| Device Materials | Vinyl and oil-based liquidNitrile compoundThe plasticizer type used isdifferent. | Vinyl and oil-based liquidNitrile compoundThe plasticizer type used isdifferent. | Similar | |
| Color | Blue | Blue | Similar | |
| Characteristics | StatedStandard | Device Performance | Result ofcomparison | |
| Predicate deviceK061562 | Subject DeviceK142409 | |||
| Tensile strength:before and afteraging | K061562:9Mpa minK14240911Mpa min | Before aging:14 MPaAfter aging:14MPa | Before aging:15.2MpaAfter aging:14.6Mpa | Similar &Both meetASTMD5250standard |
evice tolerances and specifications & Performance Data:
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Donggao Industrial Zone Zanhuang, Hebei, China 050000
K142409
| Characteristics | StatedStandard | Device Performance | Result ofcomparison | |
|---|---|---|---|---|
| Predicate deviceK061562 | Subject DeviceK142409 | |||
| Ultimateelongation:before and afteraging | 300% min | Before aging: 400%After aging:300% | Before aging: 390%After aging: 360% | Similar &Both meetASTMD5250standard |
| Freedom frompinholes | G-I,AQL2.5 | G-I, AQL2.5 | G-I, AQL1.5 | Similar &Both meetASTMD5250standard |
| Overall length | 230 for allsizes min | 245mm | 239mm | |
| Width | S: 85±5 | 82 mm | 87 mm | Similar &Both meetASTMD5250standard |
| M: 95±5 | 97mm | 97 mm | ||
| L: 105±5 | 110mm | 107 mm | ||
| XL: 115±5 | 120mm | 118 mm | ||
| Palm thickness | min0.08mm | 0.10mm | 0.08mm | |
| Finger thickness | min0.05mm | 0.10mm | 0.10mm | |
| Residual powder | Not morethan 2mgper glove | Not more than 2mgper glove | Not more than 2mgper glove | Similar &Both meetASTMD5250standard |
| Biocompatibility | ||||
| Primary skinirritation test | ISO 10993-10 | Under conditions ofthe study, not anirritant | Under conditions ofthe study, not anirritant | Similar |
| Dermalsensitization assay | ISO 10993-10 | Under conditions ofthe study, not anirritant | Under conditions ofthe study, not anirritant | Similar |
The two versions of standards referenced for predicate device and subject device are compared in the following table:
| Testing Items | ASTM D5250-00ε 4for Predicate deviceK061562 | ASTM D 5250-06(2011)for Subject DeviceK142409 | Inspectionlevel | Result ofcomparison |
|---|---|---|---|---|
| Overall Length | 230 for all sizes min | 230 for all sizes mini | S-2, AQL4.0 | Same |
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Donggao Industrial Zone Zanhuang, Hebei, China 050000
K142409
| (mm) | ||||
|---|---|---|---|---|
| Width(mm) | S: 85±5 | S: 85±5 | S-2, AQL4.0 | Same |
| M: 95±5 | M: 95±5 | |||
| L: 105±5 | L: 105±5 | |||
| XL: 115±5 | XL: 115±5 | |||
| Palm Thickness(mm) | 0.08mm min | 0.08mm min | S-2, AQL4.0 | Same |
| FingerThickness (mm) | 0.05mm min | 0.05mm min | S-2, AQL4.0 | Same |
| Tensile Beforeaging | 9Mpa min | 11Mpa min | Exceed | |
| Tensile Afteraging | 9Mpa min | 11Mpa min | S-2, AQL4.0 | Exceed |
| ElongationBefore aging | 300% min | 300% min | Same | |
| Elongation Afteraging | 300% min | 300% min | S-2, AQL4.0 | Same |
| Pinhole | AQL 2.5 | AQL 2.5 | G-I | Same |
| ResidualPowder | Not more than 2mgper glove | Not more than 2mg perglove | N=5 | Same |
Grand Work Plastic Products Co., Ltd. 's Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color 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 | Inspection Leveland AQL | Testing Results | Conclusion |
|---|---|---|---|---|
| Overall Length(mm) | 230 for all sizesmin | S-2, AQL4.0 | 239mm | Pass |
| Width(mm) | S: 85±5 | S-2, AQL4.0 | S: 87 | Pass |
| M: 95±5 | M: 97 | |||
| L: 105±5 | L: 107 | |||
| XL: 115±5 | XL: 118 |
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Donggao Industrial Zone Zanhuang, Hebei, China 050000
K142409
| Palm Thickness(mm) | 0.08mm min | S-2, AQL4.0 | 0.08mm | Pass |
|---|---|---|---|---|
| Finger Thickness(mm) | 0.05mm min | S-2, AQL4.0 | 0.10mm | Pass |
| Tensile Strength (Mpa) | ||||
| Before aging | 11Mpa min | S-2, AQL4.0 | 15.2Mpa min | Pass |
| After aging | 11Mpa min | S-2, AQL4.0 | 14.6Mpa min | Pass |
| Ultimate Elongation (%) | ||||
| Before aging | 300% min | S-2, AQL4.0 | 390% min | Pass |
| After aging | 300% min | S-2, AQL4.0 | 360% min | Pass |
| Pinhole | 2.5 | G-I | AQL1.5 | Pass |
| Residual Powder | Not more than 2mgper glove | N=5 | Not more than 2mgper glove | Pass |
| (a) Primary SkinIrritation Test | Under conditions of the study, not anirritant | Under conditions of the study, not anirritant | ||
| (b) DermalSensitizationStudy | Under conditions of the study, not anirritant | Under conditions of the study, not anirritant |
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Labeling:
It is Patient Examination Glove, Disposable, single use only and non-sterile There are no special labeling claims.
10. Conclusions:
Grand Work Plastic Products Co., Ltd's Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color 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.