(171 days)
Powder Free White Vinyl Patient Examination Gloves 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 White Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
This document describes the 510(k) premarket notification for Zibo Goldenline Plastic Products Company, Ltd.'s Powder-Free White Vinyl Patient Examination Gloves (K141613). The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, Tangshan Hengda Plastic Products Co., Ltd.'s Powder-Free Vinyl Patient Examination Gloves (K102558).
The document details the acceptance criteria used for the device, which are based on established ASTM and ISO standards for patient examination gloves. It then discusses the nonclinical tests conducted to prove that the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Powder-Free White Vinyl Patient Examination Gloves are primarily derived from various ASTM standards and 21 CFR 800.20, including:
- ASTM D5250-06 (Reaffirmation 2011): Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. This standard covers physical dimensions (length, width, thickness) and physical properties (tensile strength, elongation before and after aging).
- ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves. This standard specifies the inspection level and Acceptable Quality Limit (AQL) for pinholes.
- ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves. This standard sets the limit for residual powder.
- 21 CFR 800.20: General requirements for examination gloves, specifically regarding freedom from pinholes.
- ISO 10993-10 Third Edition 2010-08-01: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
The device performance is compared against these standards and the predicate device.
| Test / Characteristic | Acceptance Criteria (from Standards) | Reported Device Performance and Comparison to Predicate |
|---|---|---|
| General Specifications | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) - Substantially equivalent |
| Dimensions - Length | $\ge 230mm$ min (per ASTM D5250-06) | $\ge 230mm$ min for all sizes (S/M/L/XL) - Substantially equivalent |
| Dimensions - Width | Small 80-90mm, Medium 90-100mm, Large 100-110mm, X large 110-120mm (per ASTM D5250-06) | Small 83-86mm, Medium 93-96mm, Large 104-106mm, X large 113-116mm. These fall within the ASTM ranges - Substantially equivalent |
| Dimensions - Thickness | Finger 0.05mm min, Palm 0.08mm min (per ASTM D5250-06) | Finger 0.05mm min, Palm 0.08mm min - Substantially equivalent |
| Physical Properties | Before aging/after aging: Elongation $\ge 300%$, Tensile Strength $\ge 11MPa$ (per ASTM D5250-06) | Before aging/after aging: Elongation $\ge 300%$, Tensile Strength $\ge 11MPa$ - Substantially equivalent |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06 (Inspection Level I, AQL 2.5) | Meets ASTM D5151-06 (Reapproved 2011) with Holes Inspection Level I, AQL 2.5 - Substantially equivalent. The document also states "meet FDA requirements for waterleak test on pinhole AQL." |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | Results generated values below 2mg of residual powder, which meets ASTM D6124-06 (Reaffirmation 2011) - Substantially equivalent |
| Biocompatibility (Skin) | Meets ISO 10993-10:2002/Amd.1:2006 (Irritation & Sensitization) | Under the conditions of the study, not an irritant and not a sensitizer. Meets ISO 10993-10 Third Edition 2010-08-01 - Substantially equivalent |
| Materials | PVC for glove, PU for dusting/donning powder (Predicate device's materials) | PVC for glove, PU (Surface Coating Agent) for dusting/donning powder - Substantially equivalent |
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., length, width, tensile strength, pinholes, residual powder, biocompatibility). However, it consistently refers to meeting established ASTM standards. ASTM standards typically specify sampling plans and acceptable quality levels (AQLs) for these tests during manufacturing and quality control. For instance, ASTM D5151 for pinholes specifies an "Inspection Level I" and "AQL 2.5".
Data Provenance: The tests and data appear to be generated by the manufacturer, Zibo Goldenline Plastic Products Company, Ltd., in China, as indicated by the company's address and the origin of the submission. The studies are retrospective in the sense that they are presenting results from routine testing or specific evaluations conducted to demonstrate compliance with standards for the device under review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This section is not applicable as the device is a medical glove, not an AI/ML powered device requiring expert-established ground truth on data. The "ground truth" for the performance of the gloves is established by objective measurements and adherence to specified physical, chemical, and biological performance standards (ASTM, ISO).
4. Adjudication Method for the Test Set
This section is not applicable. The assessment relies on direct measurements against quantifiable standards rather than subjective human interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This section is not applicable. The device is a patient examination glove, not an AI-assisted diagnostic or prognostic system. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is a physical medical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective, standardized measurements and compliance with recognized industry standards. These include:
- Physical measurements: Length, width, thickness as per ASTM D5250.
- Performance metrics: Tensile strength and elongation (before and after aging) as per ASTM D5250.
- Defect detection: Freedom from pinholes with specific AQL as per ASTM D5151 and 21 CFR 800.20.
- Chemical properties: Residual powder amount as per ASTM D6124.
- Biocompatibility test results: Specifically, dermal irritation and sensitization studies as per ISO 10993-10, which provide objective assessments of biological response.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of a physical examination glove. The manufacturing process is controlled to produce gloves consistently meeting specifications, and quality control tests are conducted on samples from production batches.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2014
Zibo Goldenline Plastic Products Company, Ltd. C/O Chu Xiaoan Official Correspondent Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing 100083 CHINA
Re: K141613
Trade/Device Name: Powder free White Vinyl Patient examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYZ Dated: November 14, 2014 Received: November 17, 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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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141613
Device Name
Powder Free White Vinyl Patient Examination Gloves
Indications for Use (Describe)
Powder Free White Vinyl Patient Examination Gloves 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)
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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 Goldenline Plastic Products Company Limited |
|---|---|
| Submitter's address : | No 22, Century Road, Zibo, Shandong, 255000, China |
| Phone number : | (86)533-3819145 |
| Fax number : | (86)533-3819145 |
| Name of contact person: | Victor Zhao |
| Date the summary was prepared: | 2014-11-05 |
[(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 White Vinyl Patient Examination Gloves |
|---|---|
| Proprietary/Trade name: | "Powder-Free White 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 White 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, White Color, Tangshan Hengda Plastic Products Co., Ltd. K102558.
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[(a)(4)] A description of the device
Device Description: Powder-Free White 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. 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 intended use of the device
Device Intended Use: Powder-Free White 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.
| Features & Description | Predicate Device | Subject Device | Result of Comparison |
|---|---|---|---|
| Company | Tangshan Hengda Plastic Products Co.,Ltd. | Zibo Goldenline Plastic Products Company Limited | -- |
| 510(K) Number | K102558 | K141613 | |
| Product name | Powder-Free Vinyl Patient Examination Gloves, White Color | Powder-Free White Vinyl Patient Examination Gloves | 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, White Color 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 White 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. | 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) $Small 80-90 mm Medium 90-100mm Large 100-110mm X large 110-120 mm$ | Meets ASTM D5250-06 (Reapproved 2011) $Small 83-86 mm Medium 93-96 mm Large 104-106mm X large 113-116 mm$ | Substantially equivalent |
| Dimensions -- Thickness | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| 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≥11MPa | Before aging/after agingElongation ≥300%Tensile Strength≥ 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) | ASTMD6124-06(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, not an irritant and underconditions of the study, not asensitizer.SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO 10993-10 ThirdEdition 2010-08-01 | Substantiallyequivalent |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-Devices color: White-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For: | -Powder Free-Devices color: White-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For: | Substantiallyequivalent |
The Powder-Free White Vinyl Patient Examination Gloves 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 White Vinyl Patient Examination Gloves 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.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
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[(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (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 White Vinyl Patient Examination Gloves is as safe, as effective, and performs as well as the predicate device Powder-Free Vinyl Patient Examination Gloves, White Color, Tangshan Hengda Plastic Products Co.,Ltd. K102558.
§ 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.