(140 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).
This document is a 510(k) Summary for medical gloves (Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored)). It does not describe an AI/ML device but rather a physical medical device. Therefore, much of the requested information regarding AI/ML device evaluation is not applicable.
However, I can extract information related to the acceptance criteria and the "study" (which in this case refers to non-clinical testing against standards) that proves the device meets these criteria, as presented in the document for this specific medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature & Description | Acceptance Criteria (from ASTM Standard) | Reported Device Performance | Assessment |
|---|---|---|---|
| Dimensions - Length | >230mm min. (ASTM D5250-06 (Reapproved 2011)) | 230mm min for all sizes (Meets ASTM D5250-06 (Reapproved 2011)) | Substantially equivalent |
| Dimensions - Width | Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm (ASTM D5250-06 (Reapproved 2011)) | Small 84-86 mmMedium 94-96 mmLarge 104-106mmX large 113-115 mm (Meets ASTM D5250-06 (Reapproved 2011)) | Substantially equivalent |
| Dimensions - Thickness | Finger 0.05mm min.Palm 0.08mm min. (ASTM D5250-06 (Reapproved 2011)) | Finger 0.05mm min.Palm 0.08mm min. (Meets ASTM D5250-06 (Reapproved 2011)) | Substantially equivalent |
| Physical Properties (Before aging/after aging) | Elongation ≥300%Tensile Strength ≥ 11MPa (ASTM D5250-06 (Reapproved 2011)) | Elongation ≥300%Tensile Strength ≥ 11MPa (Meets ASTM D5250-06 (Reapproved 2011)) | Substantially equivalent |
| Freedom from Pinholes | Meets 21 CFR 800.20ASTM 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 | Under the conditions of the study, the device is not a sensitizer or an irritant.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 sample sizes used for testing each individual criterion (e.g., number of gloves tested for pinholes, tensile strength, etc.). It refers to meeting the requirements of specific ASTM standards. These standards typically define sampling plans that manufacturers must follow.
The provenance of the data is from the manufacturer's own testing in China, as the submitter is Zibo Yusheng Plastic Products Company Limited based in China. The testing would be considered prospective for the purpose of demonstrating conformance to standards for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "ground truth" for a physical medical device like a patient examination glove is established by adherence to recognized voluntary consensus standards (like ASTM standards) and FDA regulations. It does not involve expert consensus in the same way an AI/ML diagnostic device would. Performance is measured objectively against specified physical and chemical requirements.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation involves objective measurement against predefined standard specifications rather than interpretive or subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable for a physical medical device like an examination glove. MRMC studies are relevant for diagnostic AI/ML systems where human interpretation plays a role.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is not an algorithm or AI/ML system.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is defined by:
- Voluntary Consensus Standards: Specifically, ASTM D5250-06 (Reaffirmation 2011) for vinyl patient examination gloves, ASTM D5151-06 (Reapproved 2011) for detection of holes, and ASTM D6124-06 (Reaffirmation 2011) for residual powder.
- FDA Regulations: 21 CFR 800.20 (for freedom from pinholes).
- International Standards for Biocompatibility: ISO 10993-10 Third Edition 2010-08-01 for skin irritation and sensitization.
These standards and regulations establish the objective criteria (e.g., minimum tensile strength, maximum allowable pinholes) that the device must meet.
8. The Sample Size for the Training Set
This information is not applicable. There is no concept of a "training set" for physical medical devices like these gloves in the context of an AI/ML model. Manufacturers conduct process validation and quality control measures during manufacturing, but these are distinct from AI/ML training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set" in the AI/ML sense for this device. The manufacturer's internal quality systems and adherence to good manufacturing practices ensure consistent product quality, relying on the established performance standards mentioned above.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2014
Zibo Yusheng Plastic Products Company Limited C/O Mr. Chu Xiaoan Official Correspondent Beijing Easy-Link Co. Room 1606 Bldg 1 Yuan #209 Bei Si Huan Zhong Road, Haidian District Beijing, PR China 100083
Re: K141108
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: August 11, 2014 Received: August 14, 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 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 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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Indications for Use
510(k) Number (if known) K141108
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)
_ 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
"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
[(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 : | Zibo Yusheng Plastic Products Company Limited |
|---|---|
| Submitter's address : | Li Wang Village, Zhoujia District, Hengtai County Zibo,Shandong, 255414, China |
| Phone number : | (86)533-3819127 |
| Fax number : | (86)533-3819127 |
| Name of contact person: | Cherry Xu |
| Date the summary was prepared: | 2014-08-11 |
[(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 k nown
| 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 formthe basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conformto 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 intendeduse 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. | Zibo Yusheng Plastic Products Company Limited | -- |
| 510(K) Number | K120968 | K141108 | |
| 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 84-86 mmMedium 94-96 mmLarge 104-106mmX large 113-115 mm | Substantially equivalent |
| 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 $\geq$ 11MPa | Before aging/after agingElongation ≥300%Tensile Strength $\geq$ 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 | SKIN IRRITATION DERMALand SENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Under the conditions of thestudy, the device is not asensitizer or an irritant.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 Vnyl 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 tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identifiedin (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 Vmyl Patient Examination Gloves, Clear (Non-colored) is as safe, as effective, and performs as well as the predicatedevice, 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.