(151 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).
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.
The provided document describes a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)." The submission aims to demonstrate substantial equivalence to a predicate device already on the market (K120968).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate/ASTM Standard) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| Dimensions - Length | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Dimensions - Width | ≥230mm min. (overall)Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm (specific sizes) | 230mm min for all sizesSmall 87-90 mmMedium 94-97 mmLarge 104-108mmX large 114-117 mm | Substantially equivalent |
| Dimensions - Thickness | Meets ASTM D5250-06 (Reapproved 2011)Finger 0.05mm min.Palm 0.08mm min. | Meets ASTM D5250-06 (Reapproved 2011)Finger 0.05mm min.Palm 0.08mm min. | Substantially equivalent |
| Physical Properties (Before/After Aging) | Elongation ≥300%Tensile Strength ≥11MPa (Meets ASTM D5250-06 Reapproved 2011) | Elongation ≥300%Tensile Strength ≥11MPa (Meets ASTM D5250-06 Reapproved 2011) | Substantially equivalent |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D 5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011)Holes Inspection Level IAQL 2.5 | Substantially equivalent |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | ASTM D6124-06 (Reaffirmation 2011)Results generated values below 2mg of residual powder | Substantially equivalent |
| Biocompatibility | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10:2002/Amd.1:2006 | The test article was a non-irritant or non-sensitizer.SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 Third Edition 2010-08-01 | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test mentioned (e.g., for dimensions, tensile strength, pinholes, residual powder, or biocompatibility). It references ASTM standards (D5250-06, D5151-06, D6124-06) and ISO 10993-10, which would dictate the required sample sizes for such tests.
The data provenance is not explicitly stated. However, given that the submitter is "Shuntong Glove Co., Ltd." from China, it is highly likely that the testing and data generation occurred in China. The study is retrospective in the sense that the results are presented as already obtained data to demonstrate compliance with existing standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of device and tests conducted. The "ground truth" for glove performance is established by standardized test methods and quantitative measurements against defined criteria in ASTM and ISO standards, not by expert consensus on qualitative data.
4. Adjudication Method for the Test Set
Not applicable. As described above, performance is measured against objective standards, not through adjudication of subjective assessments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. For examination gloves, the demonstration of effectiveness primarily relies on physical and mechanical properties, not human interpretation. The study is a comparison of product specifications and performance to established industry standards and a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. Examination gloves are physical devices, not algorithms. The performance evaluation focuses on the inherent characteristics of the glove material and manufacturing quality.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective, quantitative measurements against established engineering and material science standards (ASTM and ISO standards). For example:
- Physical dimensions (length, width, thickness) are measured directly.
- Physical properties (elongation, tensile strength) are determined through mechanical testing.
- Freedom from pinholes is assessed using a water leak test specified in ASTM D5151-06.
- Residual powder is measured gravimetrically as per ASTM D6124-06.
- Biocompatibility (skin irritation and sensitization) is assessed via standardized in-vivo testing as per ISO 10993-10.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of device performance evaluation for examination gloves.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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: _ K 140243 " (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 : | Shuntong Glove Co., Ltd. |
|---|---|
| Submitter's address : | Xinghonglin, Sigezhuang 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: | 2014-04-24 |
((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: | 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 Pulin Plastic Co., Ltd. | Shuntong Glove Co., Ltd. | -- |
| 510(K) Number | K120968 | ||
| 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) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Dimensions -- Width | ≥230mm min.Meets ASTM D5250-06 (Reapproved 2011) | 230mm min for all sizesMeets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Small 80-90 mmrMedium 90-100mmLarge 100-110mmX large 110-120 mm | Small 87-90 mmMedium 94-97 mmLarge 104-108mmX large 114-117 mm | ||
| Dimensions -- Thickness | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | |
| 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 | ||
| FreedomfromPinholes | 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 | SKIN IRRITATION DERMALand SENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | The test article was a non-irritant or non- sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO 10993-10 ThirdEdition 2010-08-01 | Substantiallyequivalent |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot | -Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot | 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
Section C (rev.01)
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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.
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 tests that demonstrate that the
Section C (rev.01)
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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 .
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like strokes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
June 30. 2014
Shuntong Glove Co. Ltd. c/o Mr. Chu Xiaoan Rm. 1606 Bldg.1 Jianxiang Yuan No.209 Bei Si Huan Zhong Road Haidian District Beijing, 100083 CHINA
Re: K140243
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: I Product Code: LYZ Dated: April 24, 2014 Received: May 15, 2014
Dear Mr. 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 cither 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 - Mr. 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 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/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/Safetw/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 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,
Teiashri Puroh
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
510(k) Number (if known) K 140243
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)
2 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
PLANT PARTIC PRODUCTION FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Sreekanth Gutala -S
US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.23 20.0. 00.1.1 200300.100.1.1 =2000540490, cn=Sreekanth Gutala -S 20 4.06.30 11:28:15 -04'00'
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§ 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.