(155 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
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 leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM DS250-06(Reapproved 2011) and ASTM D5151-06(Reapproved 2011) requirements.
The provided text describes the acceptance criteria and performance of Powder Free Vinyl Patient Examination Gloves.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 (Reapproved 2011) | Meets |
| Physical Properties | ASTM standard D 5250-06 (Reapproved 2011) | Meets |
| Freedom from Pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011) and D6124-06 (Reapproved 2011) | Meets (<2mg/glove) |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in rabbits ISO 10993-10:2002/Amd.1:2006 | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | Dermal sensitization in the guinea pig ISO 10993-10:2002/Amd.1:2006 | Passes (Not a Dermal sensitization) |
| Dimensions (Length) | ASTM D5250-06 (Reapproved 2011) ≥230mm min. | 230mm min for all sizes |
| Dimensions (Width) | ASTM D5250-06 (Reapproved 2011) (Small: 80-90mm, Medium: 90-100mm, Large: 100-110mm, Xlarge: 110-120mm) | (Small: 80-85mm, Medium: 95-100mm, Large: 102-108mm, Xlarge: 113-118mm) - Considered Substantially Equivalent |
| Dimensions (Thickness) | ASTM D5250-06 (Reapproved 2011) (Finger: 0.05mm min., Palm: 0.08mm min.) | (Finger: 0.09-0.12mm, Palm: 0.09-0.12mm) - Considered Substantially Equivalent |
| Physical Properties (Elongation) | ASTM D 5250-06 (Reapproved 2011) (Before aging/after aging: ≥300%) | (Before aging/after aging: 390-420%) - Considered Substantially Equivalent |
| Physical Properties (Tensile Strength) | ASTM D 5250-06 (Reapproved 2011) (Before aging/after aging: ≥14MPa) | (Before aging/after aging: 15-20 MPa) - Considered Substantially Equivalent |
| Freedom from Pinholes (AQL) | ASTM D5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011) - Holes at Inspection Level I AQL2.5 |
| Materials used | PVC | PVC |
| Dusting or Donning Powder | PU or Surface Coating Agent | PU / Surface Coating Agent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test (e.g., number of gloves tested for pinholes, physical properties, or biocompatibility). It references adherence to ASTM and ISO standards, which typically specify sampling plans. The data provenance is not specified, but the manufacturer is based in Jiangsu, China, so it can be inferred that testing was conducted either internally or by laboratories associated with the manufacturer, likely in China. The studies are non-clinical performance tests.
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 information is not applicable. The device is a patient examination glove, and its performance is evaluated against engineering and biological standards (ASTM, ISO, CFR), not against expert clinical judgment for a diagnostic task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as there's no diagnostic judgment involved that would require adjudication. Performance is measured against objective standards.
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 a physical product (gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by the requirements of the specified international and national standards:
- ASTM standard D 5250-06 (Reapproved 2011) for dimensions and physical properties.
- 21 CFR 800.20 for freedom from pinholes.
- ASTM standard D 6124-06 (Reapproved 2011) for powder residual.
- ISO 10993-10:2002/Amd.1:2006 for biocompatibility (skin irritation and sensitization).
These standards provide objective, measurable criteria for the device's performance characteristics.
8. The sample size for the training set
This information is not applicable. The device is a manufactured product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
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Section C 510(k) Summary
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: _K131826 11
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Jiangsu Toptouch Glove Co., Ltd. |
|---|---|
| Submitter's address : | No.103 Xihu Road, Suqian, Jiangsu, 223800China |
| Phone number : | 86-527-88286077 |
| Fax number : | 86-527-88286077 |
| Name of contact person: | Mr.Zhong Miao |
| Date of preparation : | 2013-11-12 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient ExaminationGloves, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | Toptouch |
| 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. |
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
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medical procedure.
Physical and performance characteristics such as design, materials and 4.3 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 leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM DS250-06(Reapproved 2011) and ASTM D5151-06(Reapproved 2011) requirements.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
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 standard D5250-06(Reapproved 2011). | Meets |
| Physical Properties | ASTM standard D5250-06(Reapproved 2011). | Meets |
| Freedom frompinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06(Reapproved 2011).andD6124-06(Reapproved 2011). | Meets<2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbitsISO 10993-10:2002/Amd.1:2006 | PassesNot a Primary SkinIrritation |
| Dermal sensitization in theguinea pigISO 10993-10: 2002/Amd.1:2006 | 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 D5250-06 (Reapproved 2011), per ASTM requirements per ASTM D6124-06(Reapproved 2011), per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1 :2006.
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 is not needed for gloves or for most devices cleared by the 510(k) process.
| Featuresજ્Description | Predicate Device | Subject Device | Result of Comparison |
|---|---|---|---|
| Company | Zhang Jia Gang Fengyuan | Jiangsu Toptouch Glove Co., | |
| Plastic Product Co.Ltd. | Ltd. | ||
| 510(K) Number | K091663 | -- | |
| Product name | Powder Free Vinyl Patient | Powder Free Vinyl Patient | same |
| Examination Gloves, Clear | Examination Gloves, Clear | ||
| (Non-colored) | (non-colored) | ||
| Product Code | LYZ | LYZ | same |
| Size | Small/ Medium/ | Small/ Medium/ | same |
| Large/X large | Large/X large | ||
| Intend for use | Powder free Vinyl Patient | PowderfreeVinylPatient | Substantially equivalent |
| Examination Gloves, | Examination Gloves, Clear | ||
| Clear(Non-colored)is a | (Non-colored) is a disposable | ||
| disposable device intended | device intendedfor medical | ||
| for medical purposes that is | purposes that is worn on the | ||
| worn on the examiner's hand | examiner's hand or finger to | ||
| or finger to prevent | prevent contamination between | ||
| contamination between | patient and examiner. | ||
| patient and examiner. | |||
| Device | Meets ASTM D5250-06 | Meets ASTM | Substantially equivalent |
| Description and | (Reapproved 2011) | D5250-06 | |
| Specifications | (Reapproved 2011) | ||
| Dimensions | Meets ASTM | 230mm min for all sizes | Substantially equivalent |
| -- Length | D5250 -06 | ||
| (Reapproved 2011) | |||
| ≥230mm min | |||
| Dimensions | Meets ASTM D5250-06 | Substantially equivalent | |
| -- Width | (Reapproved 2011) | ||
| 80-90 mmSmall | Small80-85 mm | ||
| 90-100mmMedium | 95-100mmMedium | ||
| 100-110mmLarge | 102-108mmLarge | ||
| Xlarge110-120 mm | 113-118 mmX large | ||
| Dimensions--Thickness | Meets ASTM D5250-06(Reapproved 2011)Finger 0.05mm min.Palm 0.08mm min. | Thickness (mm) min.Finger 0.09-0.12Palm 0.09-0.12 | Substantially equivalent |
| PhysicalProperties | Meets ASTM D 5250-06(Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥ 14MPa | Before aging/after agingElongation :390-420%Tensile Strength: 15-20 MPa | Substantially equivalent |
| Freedom fromPinholes | Meets• 21 CFR 800.20• ASTM D5250-06(Reapproved 2011)• ASTM D 5151-06(Reapproved 2011) | Meets ASTMD5151-06(Reapproved 2011)Holes atInspection Level IAQL2.5 | Substantially equivalent |
| ResidualPowder | Meets ASTMD 6124-06(Reapproved 2011)below 2mg of residualpowder | Meets ASTMD 6124-06(Reapproved 2011)Results generated values below2mg of residual powder | Substantially equivalent |
| Materials usedto fabricate thedevices | PVC | PVC | Substantially equivalent |
| Dusting orDonningPowder: | PU | PU | Substantially equivalent |
| Dusting orDonningPowder: name | PU | Surface Coating Agent | Substantially equivalent |
| Compareperformancedata supportingsubstantialequivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reapproved 2011) | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reapproved 2011) | Substantially equivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially equivalent |
| Biocompatibility | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | The test article was anon-irritant and non-sensitizer.SKIN IRRITATION DERMALand SENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Substantially equivalent |
| 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 | Substantially equivalent |
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.
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2013
Jiangsu Toptouch Glove Company C/O Chu Xiaoan Beijing Easy-Link Company, Limited Room 1606 Building 1 Jian Xiang Yuan Number 209 Bei Si Huan Zhong Road Haidan District CHINA 100083
Re: K131826
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: October 14, 2013 Received: October 24, 2013
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 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 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/6/Picture/8 description: The image shows a logo with the text "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR". The logo is stylized with overlapping lines and geometric shapes. The text is arranged in a way that it is partially obscured by the logo's design. The word "FOR" is located at the bottom right of the image.
Erin Keith, M.S. Division Director, Acting Division of Anesthesia, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131826
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloved) 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)
_ Prescription Use (Part 21 CFR 801 Subpart D)
[x] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
§ 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.