(280 days)
Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) is a non-sterile 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) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided text describes the acceptance criteria and the study results for the "YONGFA Powder-Free Vinyl Patient Examination Gloves, Clear (non-colored)".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM D5250-06 (Reaffirmation 2011) standard for vinyl patient examination gloves, ASTM D5151-06 (Reapproved 2011) for freedom from pinholes, and ASTM D6124-06 (Reaffirmation 2011) for residual powder, as well as biocompatibility standards.
| Feature & Description | Acceptance Criteria (from ASTM/ISO Standards) | Reported Device Performance |
|---|---|---|
| Device Description & Specifications | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) |
| Dimensions - Length | ≥ 230mm min (ASTM D5250-06) | ≥ 230mm min for all sizes (Meets ASTM D5250-06) |
| Dimensions - Width | Small: 80-90 mm; Medium: 90-100 mm; Large: 100-110 mm; X Large: 110-120 mm (ASTM D5250-06) | Small: 86-89 mm; Medium: 94-97 mm; Large: 105-107 mm; X Large: 115-118 mm (Meets ASTM D5250-06) |
| Dimensions - Thickness | Finger: ≥ 0.05mm min; Palm: ≥ 0.08mm min (ASTM D5250-06) | Finger: ≥ 0.05mm min; Palm: ≥ 0.08mm min (Meets ASTM D5250-06) |
| Physical Properties | Before aging/after aging: Elongation ≥ 300%; Tensile Strength ≥ 11MPa (ASTM D5250-06) | Before aging/after aging: Elongation ≥ 300%; Tensile Strength ≥ 11MPa (Meets ASTM D5250-06) |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06 (Inspection Level I, AQL 2.5) | Meets ASTM D5151-06 (Inspection Level I, AQL 2.5) |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | Results generated values below 2mg of residual powder (Meets ASTM D6124-06) |
| Biocompatibility | Not an irritant; Not a sensitizer (ISO 10993-10) | Under the conditions of the study, not an irritant; Under conditions of the study, not a sensitizer. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing each specific characteristic (e.g., number of gloves tested for tensile strength or pinholes). However, the testing is based on meeting ASTM standards (D5250-06, D5151-06, D6124-06) and ISO 10993-10. These standards typically prescribe sampling plans and methodologies.
The provenance of the data is not directly stated as "retrospective" or "prospective". However, given that this is a 510(k) submission for a new device claiming substantial equivalence to an existing one, the tests would have been performed by the manufacturer, Yongfa Glove Co., Ltd., which is located in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For medical gloves, "ground truth" is typically established by recognized national/international standards and testing protocols, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
This concept (e.g., 2+1, 3+1) is not applicable to the type of device and testing described. Adjudication methods are typically used in clinical studies where human interpretation of medical images or patient conditions needs to be resolved among multiple experts. For gloves, the assessment is based on objective measurements against predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance (with and without aid) is evaluated. This document concerns the physical and biological properties of patient examination gloves.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical glove, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. Type of Ground Truth Used
The ground truth used for evaluating the device is based on established industry standards and regulatory requirements:
- ASTM Standard D5250-06 (Reaffirmation 2011): Standard Specification for Vinyl Patient Examination Gloves.
- ASTM Standard D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM Standard D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10 Third Edition 2010-08-01: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
- 21 CFR 800.20: Subpart B - Performance Standards and Requirements for Medical Devices; General.
These standards define the measurable physical properties and acceptable limits for performance characteristics of the gloves.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this device type, this question is not relevant.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
Yongfa Glove Co., LTD Chu Xiaoan Official Correspondent Room 1606, Bldg. 1 Jianxiang Yuan No. 209 Haidian District, Beijing 100083 China
Re K140246
Trade/Device Name: YONGFA Powder-Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYZ Dated: September 30, 2014 Received: October 1, 2014
Dear Mr. Xiaoan:
This letter corrects our substantially equivalent letter of November 6, 2014
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. Iisting 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 - Chu Xiaoan
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/ResourcesforYou/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/ReportalProblem/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. Clinical Deputy Director
Tejashri Purohit-Sheth, M.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140246
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 non-sterile 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)
L Prescription Use (Part 21 CFR 801 Subpart D)
Z 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Section C
510(k) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: " (applicant leave blank)
Premarket Notification [510(k)] Summary
((a)(1)). The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | Yongfa Glove Co., Ltd. |
|---|---|
| Submitter's address : | Wangguanzhai, Bencheng Town, Luannan County, HebeiProvince, 063502, China |
| Phone number : | (86) 315- 4169201 |
| Fax number : | (86) 315-4430333 |
| Name of contact person: | Zhang Liang |
| Date the summary was prepared: | 2014-09-29 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored) |
|---|---|
| Proprietary/Trade name: | "YONGFA Powder Free Vinyl Patient Examination Gloves,Clear (Non-colored)" |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital(80) |
| Product Code: | LYZ |
((a)(3)). An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device : Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd., K120968 .
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[(a)(4)] A description of the device
Device Description : Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
-- 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.
-- Physical and performance characteristics such as design, materials and physical properties:
PVC gloves are 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.
[(a)(5)] The summary describes the intended use of the device
Device Intended 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.
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
| Features & Description | Predicate Device | Subject Device | Result of Comparison |
|---|---|---|---|
| Company | Tangshan Zhonghong Plastic Co.,Ltd. | Yongfa Glove Co., Ltd. | -- |
| 510(K) Number | K120968 | K140246 | |
| 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 | Substantially equivalent |
| 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. | Meets ASTM D5250-06 (Reapproved 2011)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 | Meets ASTM D5250-06 (Reapproved 2011)Small 86-89 mmMedium 94-97 mmLarge 105-107mmX large 115-118 mm | Substantially equivalent |
| Dimensions -- Thickness | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Finger 0.05mm min.Palm 0.08mm min. | Finger 0.05mm min.Palm 0.08mm min. | ||
| Physical Properties | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent |
| Before aging/after agingElongation ≥300%Tensile Strength≥11MPa | Before aging/after agingElongation ≥300%Tensile Strength≥ 11MPa | ||
| Freedom fromPinholes | Meets• 21 CFR 800.20• ASTM D5250-06(Reapproved 2011)• ASTM D 5151-06(Reapproved 2011) | Meets ASTMD5151-06 (Reapproved 2011)HolesInspection Level IAQL2.5 | Substantiallyequivalent |
| Residual Powder | Meets ASTMD6124-06 (Reaffirmation2011) | ASTM D6124-06(Reaffirmation 2011)Results generated valuesbelow 2mg of residual powder | Substantiallyequivalent |
| Compare allmaterials used tofabricate thedevices | PVC | PVC | Substantiallyequivalent |
| Dusting orDonning Powder: | PU | PU | Substantiallyequivalent |
| Dusting orDonning Powder:name | PU | 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 thestudy, not an irritantUnder conditions of the study,not a sensitizer. | Under the conditions of thestudy, not an irritantUnder conditions of the study,not a sensitizer. | Substantiallyequivalent |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | SKIN IRRITATION DERMALand SENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006-Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For: | SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO 10993-10 ThirdEdition 2010-08-01-Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For: | Substantiallyequivalent |
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
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[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10 Third Edition 2010-08-01.
[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
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Clinical data is not needed for gloves or for most devices cleared by the 510(k) process. [(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims and 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 Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd. K120968 .
§ 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.