(186 days)
ZM 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 FDA 510(k) summary for ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). This is a medical glove, which is a Class I device and does not involve AI/ML. Therefore, many of the typical questions regarding AI/ML device studies are not applicable.
Here's the information that can be extracted from the document based on your request:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Standard / Acceptance Criteria | Device performance |
|---|---|---|
| Dimension | ASTM D5250-06(Reapproved 2011) | Meets |
| Physical Properties | ASTM D5250-06(Reapproved 2011) | Meets |
| Freedom from pinholes | 21 CFR 800.20 (and ASTM D5151-06) | Meets (Holes at Inspection Level I AQL2.5) |
| Powder Residual | ASTM D5250-06(Reapproved 2011) & D6124-06(Reaffirmation 2011) | Meets (<2mg/glove) |
| Biocompatability (Skin Irritation) | ISO 10993-10: 2010-08-01 (Primary Skin Irritation in rabbits) | Passes (Not a Primary Skin Irritation) |
| Biocompatability (Dermal Sensitization) | ISO 10993-10: 2010-08-01 (Dermal sensitization in the guinea pig) | Passes (Not a Dermal sensitization) |
| Length | ASTM D5250-06 (Reapproved 2011): ≥ 230mm min | 230mm min for all sizes |
| Width (Small) | ASTM D5250-06 (Reapproved 2011): 80-90 mm | 80-85 mm |
| Width (Medium) | ASTM D5250-06 (Reapproved 2011): 90-100 mm | 95-100mm |
| Width (Large) | ASTM D5250-06 (Reapproved 2011): 100-110 mm | 102-108mm |
| Width (X-Large) | ASTM D5250-06 (Reapproved 2011): 110-120 mm | 113-118 mm |
| Thickness (Finger) | ASTM D5250-06 (Reapproved 2011): 0.05mm min. | ≥ 0.05mm min. |
| Thickness (Palm) | ASTM D5250-06 (Reapproved 2011): 0.08mm min. | ≥ 0.08mm min. |
| Elongation (Before/After aging) | ASTM D5250-06 (Reapproved 2011): ≥ 300% | 390-420% |
| Tensile Strength (Before/After aging) | ASTM D5250-06 (Reapproved 2011): ≥ 14MPa | 15-20 MPa |
Study demonstrating device meets acceptance criteria:
The device's performance against the acceptance criteria is demonstrated through non-clinical performance data which includes testing according to:
- ASTM D5250-06 (Reapproved 2011) for physical properties and dimensions.
- ASTM D6124-06 (Reaffirmation 2011) for powder residue.
- 21 CFR 800.20 (and ASTM D5151-06) for freedom from pinholes.
- ISO 10993-10:2010-08-01 for biocompatibility (primary skin irritation and dermal sensitization).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not detailed in the provided document. The summary only states that the device "meets" the standards, implying that the required samples for each test within those standards were used. The document does not specify the exact sample sizes, country of origin, or whether the tests were retrospective or prospective.
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 is not applicable as the device is a physical medical glove, and its performance is evaluated through standardized physical, chemical, and biological testing, not through expert review of data like in AI/ML systems.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the evaluation of a medical glove. Performance is determined by meeting objective standards (e.g., tensile strength, pinhole AQL), not by expert adjudication of findings.
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 is not applicable as the device is a medical glove and not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a medical glove and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective measurements and observations against the specified international and national standards (ASTM, ISO, CFR). For example:
- Dimensional measurements (length, width, thickness) are measured directly.
- Physical properties (tensile strength, elongation) are determined through standardized mechanical testing.
- Freedom from pinholes is assessed via water leak tests as specified in 21 CFR 800.20 and ASTM D5151.
- Powder residue is measured gravimetrically.
- Biocompatibility (skin irritation, sensitization) is determined through in-vivo animal testing protocols defined by ISO 10993-10, where the "ground truth" is the observed biological response to the device material.
8. The sample size for the training set
This is not applicable as the device is a medical glove and does not utilize a training set like an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable as the device is a medical glove and does not utilize a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2015
Huailai ZM Plastic Products Co., Ltd. C/O Mr. Chu Xiaoan Official Correspondent Beijing Easy-Link Company Room F302 Bldg., 41. Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang. Chaoyang District, Beijing 100121 CHINA
Re: K142911
Trade/Device Name: ZM Powder Free Vinyl Patient Examination Gloves, Clear (noncolored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYZ Dated: February 2, 2015 Received: February 19, 2015
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 vou 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
ZM 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)
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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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:
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Huailai ZM Plastic Products Co., Ltd. |
|---|---|
| Submitter's address : | Shacheng Economic Development ZoneHuailai County, Zhangjiakou City, HebeiProvince.075400,P.R.China |
| Phone number : | 86-313-6226211 |
| Fax number : | 86-313-6216211 |
| Name of contact person: | Mr.Zhang Zhuohao |
| Date of preparation : | 2015-02-02 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient ExaminationGloves, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | ZM 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. |
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.
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 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(Reaffirmation 2011) | Meets<2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbitsISO 10993-10: 2010-08-01 | PassesNot a Primary SkinIrritation |
| Dermal sensitization in theguinea pigISO 10993-10: 2010-08-01 | PassesNot a Dermalsensitization |
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 is not needed for gloves or for most devices cleared by the 510(k) process.
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| Features&Description | Predicate Device | Subject Device | Result ofComparison |
|---|---|---|---|
| Company | Zhang Jia Gang FengyuanPlastic Product Co.Ltd.K091663 | Huailai ZM Plastic ProductsCo., Ltd.K142911 | -- |
| 510(K) Number | K091663 | K142911 | |
| Product name | Powder Free Vinyl PatientExamination Gloves, Clear(Non-colored) | Powder Free Vinyl PatientExamination 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 PatientExamination Gloves,Clear(Non-colored)is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner. | Powder free Vinyl PatientExamination Gloves, Clear(Non-colored) is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner. | Substantiallyequivalent |
| Device Descriptionand Specifications | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent |
| Dimensions--Length | Meets ASTMD5250 -06(Reapproved 2011)$\ge$ 230mm min | 230mm min for all sizes | Substantiallyequivalent |
| Dimensions-- Width | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent | |
| Small 80-90 mmMedium 90-100mmLarge 100-110mmXlarge 110-120 mm | Small 80-85 mmMedium 95-100mmLarge 102-108mmX large 113-118 mm | ||
| Dimensions--Thickness | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent | |
| Finger 0.05mm min.Palm 0.08mm min. | Thickness (mm) min.Finger $\ge$ 0.05Palm $\ge$ 0.08 | ||
| Physical Properties | Meets ASTM D 5250-06(Reapproved 2011) | Substantiallyequivalent | |
| Before aging/after agingElongation $\ge$ 300%Tensile Strength $\ge$ 14MPa | Before aging/after agingElongation :390-420%Tensile Strength:15-20 MPa | ||
| 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 I AQL2.5 | Substantiallyequivalent |
| Residual Powder | Meets ASTMD 6124-06(Reapproved 2011) | Meets ASTMD 6124-06(Reapproved 2011) | Substantiallyequivalent |
| below 2mg of residualpowder | Results generated valuesbelow 2mg of residualpowder | ||
| Materials 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 thisstudy, the test article was anon-irritant or non-sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO10993-10:2002/Amd.1:2006 | 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 |
| 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.
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.
§ 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.