(245 days)
Powder Free Yellow Vinyl Patient Examination Gloves 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 Yellow Vinyl Patient Examination Gloves 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. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
The document describes a 510(k) premarket notification for "Powder-Free Yellow Vinyl Patient Examination Gloves" (K143347). The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to a predicate device, which is also a Powder-Free Vinyl Patient Examination Glove, Yellow Color (K122920).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is evaluated against ASTM standards and FDA requirements. The table below summarizes the key acceptance criteria and the device's reported performance, as it is claimed to meet these standards.
| Acceptance Criteria | Device Performance (K143347) |
|---|---|
| Device Description & Specifications | Meets ASTM D5250-06 (Reapproved 2011) |
| Dimensions - Length | Meets ASTM D5250-06 (Reapproved 2011) ≥230mm min. for all sizes |
| Dimensions - Width | Meets ASTM D5250-06 (Reapproved 2011) Small 83-87 mm, Medium 93-97 mm, Large 103-107mm, X large 111-116 mm |
| Dimensions - Thickness | Meets ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min., Palm 0.08mm min. |
| Physical Properties (Before/After Aging) | Meets ASTM D5250-06 (Reapproved 2011) Elongation ≥ 300%, Tensile Strength ≥ 11MPa |
| Freedom from Pinholes | Meets ASTM D5151-06 (Reapproved 2011) and 21 CFR 800.20 Inspection Level I, AQL 2.5 |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) Results generated values below 2mg of residual powder |
| Biocompatibility | Meets ISO 10993-10 Third Edition 2010-08-01 Test article was a non-irritant or non-sensitizer. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for pinholes, tensile strength, etc.). However, it indicates compliance with recognized standards that would implicitly define appropriate sampling plans.
- Data Provenance: The testing appears to have been conducted by the manufacturer, Zibo Zhouheng Plastic Products Co. Ltd, in China, to demonstrate compliance with international and US standards. The data is retrospective, as it refers to tests conducted on the manufactured device for submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device submission. The "ground truth" for medical gloves is established by their adherence to defined performance specifications and safety standards (e.g., ASTM, ISO, FDA regulations) as measured through physical and chemical testing, not by expert consensus on clinical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved. For glove testing, results are objective measurements against defined criteria.
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. MRMC studies and the concept of AI assistance for human readers are relevant to AI/ML-driven diagnostic devices, not patient examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical glove, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this device is based on established performance standards and regulatory requirements. Specifically:
- ASTM Standards: ASTM D5250-06 (Reaffirmation 2011) for vinyl patient examination gloves, ASTM D5151-06 (Reapproved 2011) for freedom from holes, and ASTM D6124-06 (Reaffirmation 2011) for residual powder.
- FDA Regulations: 21 CFR 800.20 for barrier integrity.
- ISO Standard: ISO 10993-10 Third Edition 2010-08-01 for biocompatibility (skin irritation and sensitization).
These standards define the acceptable physical properties, barrier integrity, and biological safety of the gloves.
8. The Sample Size for the Training Set
This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical product and does not involve AI/ML. All testing mentioned constitutes part of the validation process against established standards.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2015
Zibo Zhouheng Plastic Products Co., Ltd c/o Chu Xiaoan Room 1606 Bldg 1 Jianxiang Yuan No.209 Bei Si Huan Zhong Road, Haidian District Beijing 100083 CHINA
Re: K143347
Trade/Device Name: Powder-Free Yellow Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 17, 2015 Received: May 26, 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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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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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) K143347
Device Name
Powder-Free Yellow Vinyl Patient Examination Gloves
Indications for Use (Describe)
Powder Free Yellow Vinyl Patient Examination Gloves 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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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."
" (applicant leave blank) "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 Zhouheng Plastic Products Co. Ltd | |
|---|---|---|
| Submitter's address : | Sanying Road, Zibo, Shandong, 255087, China | |
| Phone number・ | (86)533-3819122 | |
| Fax number | (86)533-3819122 | |
| Name of contact person: | Cherry Xu | |
| Date the summary was prepared: | 2015-04-17 |
[(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 Yellow Vinyl Patient Examination Gloves |
|---|---|
| Proprietary/Trade name: | "Powder-Free Yellow Vinyl Patient Examination Gloves" |
| 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device: Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920.
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[(a)(4)] A description of the device
Device Description: Powder-Free Yellow Vinyl Patient Examination Gloves 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. 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 Yellow Vinyl Patient Examination Gloves 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.
The Powder-Free Yellow Vinyl Patient Examination Gloves non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Features &Description | Predicate Device | Subject Device | Result of Comparison |
|---|---|---|---|
| Company | Hebei Leader Plastic Co., Ltd. | Zibo Zhouheng Plastic Products Co. Ltd | -- |
| 510(K) Number | K122920 | K143347 | |
| Product name | Powder-Free Vinyl Patient Examination Gloves, Yellow Color | Powder-Free Yellow Vinyl Patient Examination Gloves | Same |
| Product Code | LYZ | LYZ | Same |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | Substantiallyequivalent |
| Intend for use | Powder Free Vinyl Patient Examination Gloves. Colored (Yellow) 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 Yellow Synthetic Vinyl Patient Examination Gloves 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. | Substantiallyequivalent |
| DeviceDescription andSpecifications | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250 -06(Reapproved 2011) | Substantiallyequivalent |
| Dimensions-- Length | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent |
| ≥230mm min. | 230mm min for all sizes | ||
| Dimensions-- Width | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent |
| Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm | Small 83-87 mmMedium 93-97 mmLarge 103-107mmX large 111-116 mm | ||
| Dimensions-- Thickness | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent |
| 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 $\geq$ 300%Tensile Strength $\geq$ 11MPa | Before aging/after agingElongation $\geq$ 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 | 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: Yellow-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot | -Powder Free-Devices color: Yellow-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot | Substantiallyequivalent |
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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 Yellow Vinyl Patient Examination Glovesmeet 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 device is as safe, as effective, and performed as well or better than the legally marketed device
Section C
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identified in (a)(3).
It can be concluded that the Powder-Free Yellow Synthetic 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 Yellow Vinyl Patient Examination Gloves is as safe, as effective, and performs as well as the predicate device Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920.
§ 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.