(100 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).
The provided document describes a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" manufactured by Shijiazhuang Aok Plastic Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are primarily based on meeting various ASTM standards and FDA regulations, demonstrating equivalence to the predicate device. The performance of the subject device is stated to meet these same standards and specifications.
| Feature | Acceptance Criteria (Predicate Device / Standard) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| General | |||
| 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 |
| Intended Use | Disposable device intended for medical purposes, worn on examiner's hand/finger to prevent cross-contamination. | Disposable device intended for medical purposes, worn on examiner's hand/finger to prevent cross-contamination. | Substantially equivalent |
| Physical Properties | |||
| Device Description & Specs | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250 -06 (Reapproved 2011) | Substantially equivalent |
| Length | Meets ASTM D5250-06 (Reapproved 2011), ≥230mm min. | Meets ASTM D5250-06 (Reapproved 2011), 230mm min for all sizes | Substantially equivalent |
| 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 85-87 mm Medium 93-97 mm Large 103-106mm X large 113-115 mm | Substantially equivalent |
| Thickness | Meets ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min. Palm 0.08mm min. | Meets ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min. Palm 0.08mm min. | Substantially equivalent |
| Elongation (Before/After aging) | Meets ASTM D5250-06 (Reapproved 2011), ≥300% | Meets ASTM D5250-06 (Reapproved 2011), ≥300% | Substantially equivalent |
| Tensile Strength (Before/After aging) | Meets ASTM D5250-06 (Reapproved 2011), ≥11MPa | Meets ASTM D5250-06 (Reapproved 2011), ≥11MPa | Substantially equivalent |
| Performance Characteristics | |||
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D 5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011) Holes Inspection Level I, AQL 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 | Under the conditions of this study, the test article was a non-irritant and non-sensitizer. (Predicate's reported claim) | Under the conditions of this study, the test article was a non-irritant and non-sensitizer. | Substantially equivalent |
| Labeling for Biocompatibility | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10:2002/Amd.1:2006 (Predicate's reported standard) | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 Third Edition 2010-08-01 | Substantially equivalent |
| Materials | PVC, PU (as Dusting or Donning Powder) | PVC, PU (as Dusting or Donning Powder / Surface Coating Agent) | Substantially equivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | 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 specific characteristic. However, it references conformity to ASTM and ISO standards (e.g., ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 10993-10). These standards typically define the sampling plans and methodologies for testing.
- Data Provenance: The tests were conducted to demonstrate conformity to international and national standards (ASTM, ISO). The manufacturing company is Shijiazhuang Aok Plastic Co., Ltd. located in China. The testing data would likely be from retrospective tests performed on newly manufactured devices by the applicant or a certified testing laboratory.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (patient examination gloves) does not typically involve "ground truth" established by human experts in the context of diagnostic interpretation. The "ground truth" for performance is based on quantifiable measurements against established engineering and material standards. Therefore, information about experts and their qualifications for establishing ground truth is not applicable to this submission.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are common in studies involving subjective interpretation (e.g., medical imaging). For the physical and performance testing of medical gloves, measurements are typically objective and quantitative, and thus no adjudication method as typically understood in medical device AI/diagnostic studies is used. Testing laboratories follow standardized protocols for obtaining measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are used to evaluate the impact of a device (often AI-based diagnostics) on human reader performance. This submission is for a physical medical device (gloves) with performance criteria based on manufacturing and material standards, not diagnostic interpretation.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is not an algorithm or software-based device. Performance is assessed through physical and chemical testing of the manufactured product.
7. Type of Ground Truth Used
The "ground truth" for this device is based on established engineering and material standards (e.g., ASTM D5250-06 for physical properties, ASTM D5151-06 for pinholes, ASTM D6124-06 for residual powder, and ISO 10993-10 for biocompatibility). These standards define objective pass/fail criteria and test methods.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no training set in the conventional sense. The product is manufactured and tested according to specified quality control processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for a training set. The "ground truth" for ensuring quality manufacturing is embedded within the referenced ASTM and ISO standards for material properties and testing protocols.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2014
Shijiazhuang Aok Plastic Co., Ltd. C/O Mr. Chu Xiaoan Official Correspondent Rm. 1606 Bldg.1 Jianxiang Yuan No.209 Bei Si Huan Zhong Road Haidian District Beijing, 100083 CHINA
Re: K141307
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 12, 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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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/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin | Keith -S
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) K141307
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 : | Shijiazhuang Aok Plastic Co.,Ltd. |
|---|---|
| Submitter's address : | No.78 Binhe Road,Jinzhou City, Hebei, 052260, China |
| Phone number : | (86)311-85125612 |
| Fax number : | (86)311-85125612 |
| Name of contact person: | Meng Yunmiao |
| Date the summary was prepared: | 2014-08-12 |
[(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 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 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 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 PulinPlastic Co.,Ltd. | Shijiazhuang Aok PlasticCo.,Ltd. | -- |
| 510(K) Number | K120968 | K141307 | Same |
| 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 | Substantiallyequivalent |
| Intend for use | Powder free Vinyl PatientExamination Gloves,Clear(Non-colored)is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. | Powder free Vinyl PatientExamination Gloves, Clear(Non-colored) is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contaminationbetween 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 85-87 mmMedium 93-97 mmLarge 103-106mmX large 113-115 mm | ||
| Dimensions-- Thickness | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | |
| Physical Properties | Finger 0.05mm min.Palm 0.08mm min.Meets ASTM D5250-06(Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥11MPa | Finger 0.05mm min.Palm 0.08mm min.Meets ASTM D5250-06(Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥ 11MPa | Substantiallyequivalent |
| 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 | Under the conditions of thisstudy, the test article was anon-irritant and non-sensitizer. | Under the conditions of thisstudy, the test article was anon-irritant andnon-sensitizer. | Substantiallyequivalent |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | SKIN IRRITATION DERMALand SENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO 10993-10 ThirdEdition 2010-08-01 | Substantiallyequivalent |
| -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 |
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.
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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.
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 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 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.