(159 days)
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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.
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (viny) 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 D5250 and ASTM D5151 requirements.
Here's a summary of the acceptance criteria and the study details for the Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, based on the provided 510(k) summary:
This device is a Class I medical device (K131828), which typically requires less rigorous clinical testing compared to Class II or III devices. The submission focuses on demonstrating substantial equivalence to a predicate device (K110972) through non-clinical performance testing.
1. Acceptance Criteria and Reported Device Performance
| Characteristics | Standard / Acceptance Criteria | 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 (and ASTM D5250-06, ASTM D5151-06) | Meets (Holes at Inspection Level 1 AQL 2.5) |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011) & D6124-06 (Reapproved 2011) | Meets (<2mg/glove) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10:2002/Amd.1:2006 (in rabbits) | Passes (Not a Primary Skin Irritant) |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10:2002/Amd.1:2006 (in guinea pig) | Passes (Not a Dermal Sensitizer) |
| Length (Minimum) | ASTM D5250-06 (Reapproved 2011) >230mm min. | 230mm min for all sizes |
| Width | ASTM D5250-06 (Reapproved 2011) (Ranges for S, M, L, XL) | Small 80-85 mm, Medium 95-97 mm, Large 102-108mm, X large 114-118 mm |
| Thickness (Minimum) | ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min., Palm 0.08mm min. | Finger 0.09-0.12 mm, Palm 0.09-0.12 mm |
| Physical Properties (Elongation) | ASTM D5250-06 (Reapproved 2011) ≥300% (before/after aging) | 330-420% (before/after aging) |
| Physical Properties (Tensile Strength) | ASTM D5250-06 (Reapproved 2011) ≥ 14MPa (before/after aging) | 15-18 MPa (before/after aging) |
| Materials Used | Identified as a polymer or other material | PVC |
| Dusting/Donning Powder | Composition identified | PU (Surface Coating Agent) |
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., pinhole, tensile strength, biocompatibility). It references adherence to ASTM and ISO standards, which would dictate the required sample sizes for those tests.
The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective. It implies the performance data was generated through laboratory testing based on the cited standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device's performance is evaluated against established engineering and biocompatibility standards (ASTM, ISO, CFR), not through expert interpretation of medical images or conditions. The "ground truth" for glove performance relies on objective measurements against these standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, the performance is based on objective measurements against established standards, not on expert adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not relevant for this type of device. The evaluation of patient examination gloves focuses on their physical properties, barrier integrity, and biocompatibility, not on the interpretative performance of human readers aided by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for evaluating this device's performance is based on established industry standards and regulatory requirements:
- ASTM D5250-06 (Reapproved 2011): Standard for Poly(vinyl chloride) Gloves for Medical Application.
- ASTM D5151-06 (Reapproved 2011): Standard for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2011): Standard Test Method for Residual Powder on Medical Gloves.
- 21 CFR 800.20: Code of Federal Regulations pertaining to barrier integrity.
- ISO 10993-10:2002/Amd.1:2006: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve machine learning algorithms that require 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.
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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: ______________________________________________________________________________________________________________________________________________
Premarket Notification [510(k)] Summary
NOV 2 6 2013
- 1.0 Submitter:
| Submitter's name : | Jiangsu Handsafe Glove Co., Ltd. |
|---|---|
| Submitter's address : | Century Road, The Economic DevelopmentZone, Suqian, Jiangsu, 223800 China |
| Phone number : | 86-527-88286058 |
| Fax number : | 86-527-88286058 |
| Name of contact person: | Ms.Sha Sophia |
| Date of preparation : | 2013-11-21 |
Name of the Device 2.0
| Device Name: | Powder Free Vinyl Patient ExaminationGloves, Light Yellow Color |
|---|---|
| Proprietary/Trade name: | Handsafe |
| 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 GloveLight Yellow Color |
|---|---|
| Company name: | PPP Medical and Safety Products Limited |
| 510(K) Number: | K110972. |
4.0 Device Description:
How the device functions: 4.1 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. Its tensile properties cause it to conform to the hand, allowing movements necessary for a
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medical procedure.
4.3 Physical and performance characteristics such as design, materials and physical properties:
Poly (viny) 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 D5250 and ASTM D5151 requirements.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, 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 SkinIrritant |
| Dermal sensitization in theguinea pigISO 10993-10: 2002/Amd.1:2006 | PassesNot a DermalSensitizer |
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7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, meet requirements per ASTM D5250-06 (Reapproved 2011), 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.
| Features &Description | Predicate Device | Medical GloveGuidance Manual | Subject Device | Result ofComparison | |
|---|---|---|---|---|---|
| Company | PPP Medical andSafety ProductsLimited. | Jiangsu Handsafe GloveCo., Ltd. | -- | ||
| 510(K) Number | K110972 | K131828 | |||
| Product name | Powder-Free VinylPatient ExaminationGlove, Light YellowColor | Powder Free VinylPatient ExaminationGloves, Light YellowColor | same | ||
| Product Code | LYZ | LYZ | LYZ | same | |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | same | ||
| Intend for use | Powder Free VinylPatient ExaminationGloves, Light YellowColor is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand orfinger to preventcontamination betweenpatient and examiner. | Powder FreeExamination Gloves:A powder-free patientexamination glove is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontamination betweenpatient and examiner. | Powder Free VinylPatient ExaminationGloves, Light YellowColor is a disposabledevice intended formedical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. | Substantiallyequivalent | |
| DeviceDescription andSpecifications | Meets ASTMD5250-06(Reapproved 2011) | If vinyl:Do the vinylexamination glovesmeet all the currentspecifications listedunder ASTMSpecification D5250or an equivalentconsensus standard? | Meets ASTMD5250-06(Reapproved 2011) | Substantiallyequivalent | |
| Dimensions-Length | Meets ASTMD5250 -06(Reapproved 2011)>230mm min | ASTM D5250 | 230mm min for all sizes | Substantiallyequivalent | |
| Dimensions | ASTM D5250 | Substantiallyequivalent | |||
| -- Width | Meets ASTMD5250-06(Reapproved 2011) | ||||
| Small 80-90 mmMedium 90-100mmLarge 100-110mmXlarge 110-120 mm | Small 80-85 mmMedium 95-97 mmLarge 102-108mmX large 114-118 mm | ||||
| Dimensions--Thickness | Meets ASTMD5250-06(Reapproved 2011) | Substantiallyequivalent | |||
| Finger 0.05mm min.Palm 0.08mm min. | Thickness (mm) min.Finger 0.09-0.12Palm 0.09-0.12 | ||||
| PhysicalProperties | Meets ASTM D5250-06(Reapproved 2011) | ASTM D5250 | Substantiallyequivalent | ||
| Before aging/after agingElongation ≥300%Tensile Strength≥ 14MPa | Before aging/after agingElongation :330-420%Tensile Strength:15-18 MPa | ||||
| Freedom fromPinholes | Meets• 21 CFR 800.20• ASTM D5250-06(Reapproved 2011)• ASTM D 5151-06(Reapproved 2011) | 21 CFR 800.20ASTM D5250ASTM D 5151 | Meets ASTMD5151-06(Reapproved 2011)Holes atInspection Level 1AQL2.5 | Substantiallyequivalent | |
| ResidualPowder | Meets ASTMD 6124-06(Reapproved 2011)below 2mg of residualpowder | ASTM D 6124 | Meets ASTMD 6124-06(Reapproved 2011)Results generated valuesbelow 2mg of residualpowder | Substantiallyequivalent | |
| Materials usedto fabricate thedevices | PVC | If the glove is madeof a polymer or othertype of material.identify the material. | PVC | Substantiallyequivalent | |
| Dusting orDonningPowder: | PU | If a donning lubricantis used, state thecompositionand includebiocompatibility datafor the lubricant in anidentified attachment;also state the name,manufacturer, andaddress below | PU | Substantiallyequivalent | |
| Dusting orDonningPowder: name | PU | LubricantGeneric Name/LubricantBrand Name | Surface Coating Agent | Substantiallyequivalent | |
| Compareperformancedata supportingsubstantialequivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06 | At this time FDArecognizes thefollowing standards:Patient ExaminationGloves(PVC)ASTMD5151(Detection of | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06 | Substantiallyequivalent | |
| (Reapproved 2011) | Holes in MedicalGloves)ASTMD6124(ResidualPowder on MedicalGloves)ASTMD5250(Poly(vinylchloride) Gloves) | (Reapproved 2011) | |||
| Single Patient Use | Single Patient Use | Single Patient Use | Single Patient Use | Substantiallyequivalent | |
| Biocompatibility | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.I:2006 | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIESISO 10993-10 | The test article was anon-irritant ornon-sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Substantiallyequivalent | |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-Patient ExaminationGlove-Single Use Only-Manufactured For:- Lot-Yellow color- non sterile | Chapter 4 | -Powder Free-Patient ExaminationGlove-Single Use Only-Manufactured For:- Lot-Yellow color- non sterile | 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, Light Yellow Color meet the ASTM standard or equivalent standard and FDA requirements for waterieak test on pinhole AQL., meet labeling claims.
It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is as safe, as effective, and performs as well as the predicate device, Powder-Free Vinyl Patient Examination Glove, Light Yellow Color PPP Medical and Safety Products Limited. K110972.
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an emblem featuring three stylized, curved shapes that resemble a person embracing another person.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
Jiangsu Handsafe Glove Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company Room 1606 Bldg 1 Jiangxiang Yuan #209 Bei Si Huan Zhong Road, Haidian District Beijing CHINA 100083
Re: K131828
Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves, Light Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 21, 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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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 (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 guestions 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 contains the text "Erif Disith". The text is in a bold, sans-serif font. The letters are tightly spaced together, and the word appears to be a brand name or product name. The text is black and the background is white.
Erin Keith M.S. Acting 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: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K131828
Device Name
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile disposable device intended for medical purposes I owda 1100 villy. I and or finger to prevent contamination between patient and examiner.
இ Over-The-Counter Use (21 CFR 801 Subpart C)
[] Prescription Use (Part 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR FOR FOR USE ONE ONE ONE FOR FOR THE FOR THE mence of Center for Devices and Rediological Health (CDRH) (Signature)
Image /page/7/Picture/13 description: The image shows the text "Elizabeth F. Claverie-S 2013.11.26 00.05'00'". The text is in black and is on a white background. The text is likely a date or a time stamp.
FORN FDA 3881 (9/13)
total (127) 413-6740 P PCC Dobliching Ber
§ 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.