(148 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
The provided document describes the acceptance criteria and the study that proves Daxwell, LLC's Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet those criteria, primarily through a comparison to a predicate device and adherence to established ASTM and ISO standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2011) | |
| Length | ≥230mm | 232-240mm |
| Width (Small) | 80-90mm | 81-90mm |
| Width (Medium) | 90-100mm | 93-98mm |
| Width (Large) | 100-110mm | 102-109mm |
| Width (X-Large) | 110-120mm | 110-118mm |
| Thickness (Fingertip) | ≥0.05mm | 0.08-0.11mm |
| Thickness (Palm) | ≥0.08mm | 0.09-0.12mm |
| Physical Properties | ASTM D 5250-06(Reapproved 2011) | |
| Tensile strength (Before & After aging) | ≥11MPa | 15-20MPa |
| Elongated rate (Before & After aging) | ≥300% | 360-420% |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D5151-06 (Reapproved 2011), Inspection Level I AQL2.5 | Passed Standard (Waterleak test), Meets ASTM D5151-06 (Reapproved 2011) |
| Powder Residual | ASTM D 5250-06 (Reapproved 2011) and D6124-06 (Reaffirmation 2011) | Meets <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10: 2010-08-01) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in the guinea pig (ISO 10993-10: 2010-08-01) | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, dimensions, or physical properties). It refers to adherence to standards like ASTM D5250, ASTM D5151, ASTM D6124, 21 CFR 800.20, and ISO 10993-10, which would inherently include specified sampling plans for testing. However, the exact count of items tested via these standards is not provided.
The data provenance is not explicitly stated in terms of country of origin but is based on non-clinical performance data conducted to support a "substantial equivalence" determination. Given the submitter's address (Houston, TX, USA) and the Beijing agent's address (China), and the product's likely manufacturing location, it's probable the testing was conducted in facilities accustomed to these international standards. The data is retrospective, as it's being submitted for premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is typically not applicable to medical devices like examination gloves. The "ground truth" for these devices is established by adherence to recognized national and international standards (e.g., ASTM, ISO), which specify objective measurement methods and pass/fail criteria. There are no human experts "establishing ground truth" in the way one might for diagnostic imaging interpretation.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the assessment relies on objective measurements against predefined standards. There is no subjective human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed for evaluating the performance of diagnostic devices, often involving human readers interpreting medical images or data. This is not relevant for examination gloves, which are physical barrier devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a conceptual sense. The "standalone" performance here refers to the device itself meeting the objective physical, chemical, and biological criteria outlined in the standards, without human interaction influencing the test outcome or interpretation beyond standard lab procedures. The device's performance is assessed purely on its intrinsic properties.
7. The Type of Ground Truth Used
The ground truth used is primarily objective performance standards from recognized bodies:
- ASTM (American Society for Testing and Materials) standards: D5250 (Vinyl Patient Examination Gloves), D5151 (Detection of Holes in Medical Gloves), D6124 (Residual Powder on Medical Gloves).
- 21 CFR 800.20: FDA regulation concerning medical gloves.
- ISO 10993-10: Biological evaluation of medical devices - Tests for irritation and skin sensitization.
The "ground truth" is that if the glove meets the specified numerical/qualitative criteria (e.g., tensile strength ≥11MPa), then it performs as expected for its intended use.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is based on manufacturing processes and adherence to quality control measures, which are then verified through testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2015
Daxwell, LLC c/o Chu Xiaoan Beijing Easylink CO., LTD Rm. F302 Bldg., 41. Jing Cheng Ya Ju Courtyard 6 of Southern Dou Ge Zhang Chaoyang District Beijing 100121 CHINA
Re: K151682
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: Class I Product Code: LYZ Dated: October 4, 2015 Received: October 16, 2015
Dear Mr. Chu Xiaoan:
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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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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education 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
Enclosure
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Indications for Use
510(k) Number (if known) K151682
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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)
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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Section C 510(k) Summary
510(K) Summary
"The assigned 510(k) number is: _ _ _ K151682
Premarket Notification [510(k)] Summary
0.0 Application correspondent:
| Company name | Beijing Easy-Link Company |
|---|---|
| Company address | Rm. F302 Bldg., 41, Jing Cheng Ya Ju,Courtyard 6 of Southern Dou Ge Zhuang,Chaoyang District, Beijing 100121,P.R.China |
| Contact Person | Chu Xiaoan |
| Contact E-mail address | easylink_bj@aliyun.com |
1.0 Submitter:
| Submitter's name : | Daxwell, LLC |
|---|---|
| Submitter's address : | Address: 2825 Wilcrest Dr., Suite# 500Houston, TX 77042,USA. |
| Phone number : | (281)669-0622 |
| Fax number : | (281)669-0617 |
| Name of contact person: | Frank Zhang |
| Date of preparation : | 2015-11-17 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient ExaminationGloves, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient ExaminationGloves, Clear (non-colored) |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
3.0 Predicate device
| Device Name: | Powder-Free Vinyl Patient Examination Glove(Non-colored) |
|---|---|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd. |
| 510(K) Number: | K091663. |
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4.0 Device Description:
4.1 How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
4.2 Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
- 4.3 Physical and performance characteristics such as design, materials and physical properties:
Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), non-sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance | ||
|---|---|---|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2011). | |||
| Length | ≥230mm | 232-240mm | ||
| Width | Small | 80-90 mm | 81-90mm | |
| Medium | 90-100mm | 93-98mm | ||
| Large | 100-110mm | 102-109mm | ||
| X large | 110-120 mm | 110-118mm | ||
| Thickness | Fingertip | ≥0.05mm | 0.08-0.11 mm | |
| Palm | ≥0.08mm | 0.09-0.12 mm | ||
| Physical Properties | ASTM D 5250-06(Reapproved 2011). | |||
| Tensile strength(Before & After aging) | ≥11MPa | 15-20MPa | ||
| Elongated rate(Before & After aging) | ≥300% | 360-420% | ||
| Freedom frompinholes | • | 21 CFR 800.20 | Passed Standard | |
| • | ASTM D5250-06(Reapproved 2011) | Acceptance Criteria | ||
| • | ASTM D5151-06(Reapproved 2011) | |||
| Powder Residual | ASTM standard D 5250-06 (Reapproved2011).and D6124-06(Reaffirmation 2011) | Meets<2mg/glove | ||
| Biocompatibility | Primary Skin Irritation in rabbitsISO 10993-10: 2010-08-01 | PassesNot a Primary SkinIrritation | ||
| Dermal sensitization in the guinea pigISO 10993-10: 2010-08-01 | PassesNot a Dermalsensitization |
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7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 (Reapproved 2011), per ASTM D6124-06 Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10:2010-08-01.
The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not required for this submission.
| Features & Description | Predicate Device | Subject Device | Result of Comparison |
|---|---|---|---|
| Company | Zhang Jia Gang Fengyuan Plastic Product Co.Ltd. | Daxwell, LLC | -- |
| 510(K) Number | K091663 | K151682 | |
| Product name | Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | same |
| Product Code | LYZ | LYZ | same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | same |
| Intend for use | Powder free Vinyl Patient Examination Gloves, Clear(Non-colored)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. | Powder free Vinyl Patient Examination Gloves, Clear (Non-colored) 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. | Substantially equivalent |
| Device Description and Specifications | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Dimensions --Length | Meets ASTM D5250 -06 (Reapproved 2011)≥230mm min | 230mm min for all sizes | Substantially equivalent |
| Dimensions -- Width | Meets ASTM D5250-06 (Reapproved 2011)Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm | Small 81-90 mmMedium 93-98mmLarge 102-109mmX large 110-118 mm | Substantially equivalent |
| Dimensions --Thickness | Meets ASTM D5250-06 (Reapproved 2011)Finger 0.05mm min.Palm 0.08mm min | Thickness (mm) min.Finger 0.08-0.11Palm 0.09-0.11 | Substantially equivalent |
| Physical Properties | Meets ASTM D 5250-06(Reapproved 2011) | Substantiallyequivalent | |
| Before aging/after agingElongation ≥300%Tensile Strength≥ 14MPa | Before aging/after agingElongation : 360-420%Tensile Strength:15-20 MPa | ||
| FreedomfromPinholes | Meets• 21 CFR 800.20• ASTM D5250-06(Reapproved 2011)• ASTM D 5151-06(Reapproved 2011) | Meets ASTMD5151-06(Reapproved 2011)Holes atInspection Level I AQL2.5 | Substantiallyequivalent |
| Residual Powder | Meets ASTMD 6124-06(Reapproved 2011)below than 2 mg ofresidual powder per glove | Meets ASTMD 6124-06(Reapproved 2011)below than 2 mg ofresidual powder per glove | Substantiallyequivalent |
| Materials used tofabricate thedevices | PVC | PVC | Substantiallyequivalent |
| Dusting orDonning Powder: | PU | PU | Substantiallyequivalent |
| Dusting orDonning Powder:name | Surface Coating Agent | Surface Coating Agent | Substantiallyequivalent |
| Compareperformance datasupportingsubstantialequivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011) | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011) | Substantiallyequivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantiallyequivalent |
| Biocompatibility | Under the conditions of thisstudy, the test article was anon- irritant or non-sensitizer. | Under the conditions of thisstudy, the test article was anon- irritant or non-sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10 Third Edition2010-08-01 | Substantiallyequivalent |
| SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO10993-10:2002/Amd.1:2006 | |||
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed | -Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot | -Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot | Substantiallyequivalent |
9.0 Substantial Equivalence Comparison:
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10.0 Substantial Equivalence Comparison:
It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.
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It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091663.
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed 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.