(101 days)
The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is available in three different colors: White, Blue, and Yellow. The proposed device was tested according to the following standards: ASTM D 6124-06, ASTM D 5151-06, ASTM D5250-06, ISO 10993-10:2010 and ISO 2859-1:2009.The proposed device is non-sterile.
The provided document is a 510(k) Pre-market Notification for Vinyl Examination Gloves. This type of device is a Class I medical device, which falls under general controls and does not typically require extensive clinical data or complex performance studies like those seen for higher-risk devices (e.g., AI/ML-driven diagnostic tools).
Therefore, the typical "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of an AI/ML device, as requested in the prompt, are not applicable to this document.
For Vinyl Examination Gloves, "acceptance criteria" primarily relate to material properties, performance standards for physical integrity, and biocompatibility, rather than diagnostic accuracy or human performance improvement. The "study" proving these criteria are met consists of non-clinical, laboratory-based tests.
Here's how to interpret the document in the context of the prompt, while acknowledging the fundamental difference in device type:
Device: Vinyl Examination Gloves (White, Blue, Yellow)
Submission Number: K163168
Predicate Device: K150224 Blue Vinyl Examination Gloves Powder Free
Basis for "Acceptance Criteria" and "Proof":
For this Class I device, "acceptance criteria" are defined by recognized consensus standards to ensure the gloves are safe and effective for their intended use. "Proof" is provided through non-clinical bench testing demonstrating compliance with these standards and comparability to a legally marketed predicate device.
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/ML device, specific "performance" metrics for diagnostic accuracy are not relevant. Instead, the performance metrics relate to the physical and biological characteristics of the gloves. The "acceptance criteria" are the minimum requirements set by the ASTM and ISO standards, and the "reported device performance" indicates that the proposed device met or exceeded these.
Table 1: Acceptance Criteria (Referenced Standards) and Reported Device Compliance
| Metric / Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance** |
|---|---|---|
| Product Code | LYZ (Predicate device) | LYZ |
| Regulation No. | 21 CFR 880.6250 (Predicate device) | 21 CFR 880.6250 |
| Class | I (Predicate device) | I |
| Intended Use | Defined as preventing contamination | "A disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner." (Same as predicate) |
| Powder/Powder Free | Powder Free (Predicate device) | Powdered free |
| Design Feature | Ambidextrous (Predicate device) | ambidextrous |
| Labeling | Consistent with predicate / FDA recommendations | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile (Same as predicate) |
| Dimensions (Length) | ASTM D5250 (e.g., L: 230mm min for Proposed; S: 240mm min for Predicate) | Proposed: XS: 230mm, S: 230mm, M: 235mm, L: 245mm, XL: 245mm (min) Predicate: S: 240mm, M: 240mm, L: 240mm, XL: 240mm (min) Analysis 1: Proposed device meets ASTM D5250 specifications despite size differences with predicate. |
| Dimensions (Width) | ASTM D5250 (e.g., L: 105 $\pm$ 5 mm) | Proposed: XS: 80mm, S: 85mm, M: 95mm, L: 105mm, XL: 115mm ($\pm 5$ mm) Predicate: S: 85mm, M: 95mm, L: 105mm, XL: 115mm ($\pm 5$ mm) |
| Dimensions (Thick.) | ASTM D5250 (Finger/Palm min) | Proposed: Finger: 0.05mm min, Palm: 0.08mm min Predicate: Finger: 0.10mm min, Palm: 0.08mm min |
| Physical Prop. (Tensile Strength) | Before Aging: 11 MPa min (ASTM D5250) | Proposed: 15 MPa, min Predicate: 13 MPa, min Both comply with ASTM D5250 (11 MPa min) |
| Physical Prop. (Ultimate Elongation) | Before Aging: 300% min (ASTM D5250) | Proposed: 380% min Predicate: 400% min Both comply with ASTM D5250 (300% min) |
| Physical Prop. (Tensile Strength) | After Aging: 11 MPa min (ASTM D5250) | Proposed: 15 MPa, min Predicate: 13 MPa, min Both comply with ASTM D5250 (11 MPa min) |
| Physical Prop. (Elongation) | After Aging: 300% min (ASTM D5250) | Proposed: 380% min Predicate: 400% min Analysis 3: Proposed device meets ASTM D5250 specifications despite differences with predicate. Both comply with ASTM D5250 (300% min). |
| Freedom from Holes | ASTM D5151, AQL 1.5 | "Be free from holes when tested in accordance with ASTM D5151 AQL 1.5" (Predicate uses AQL 2.5/Inspection Level G-I; Proposed is stricter AQL) |
| Powder Content | Less than 2mg per glove (ASTM D5250) | White: 0.50 mg per glove, Blue: 0.60 mg per glove, Yellow: 0.70 mg per glove All meet ASTM D5250 requirement. |
| Biocompatibility (Irritation) | Not an irritant (ISO 10993-10) | "Under the conditions of the study, not an irritant" Comply with ISO 10993-10 |
| Biocompatibility (Sensitization) | Not a sensitizer (ISO 10993-10) | "Under conditions of the study, not a sensitizer." Comply with ISO 10993-10 |
Footnote: The acceptance criteria are largely based on the predicate device's performance and/or compliance with the specified ASTM/ISO standards. Performance shows general compliance and sometimes superior values (e.g., tensile strength for proposed device).
2. Sample sized used for the test set and the data provenance
- Sample Size: The document does not specify the exact numerical sample sizes for each non-clinical test (e.g., how many gloves were tested for holes or tensile strength). However, it refers to standards like ISO 2859-1 (Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection) for sampling, which implies that appropriate statistically relevant sample sizes were used according to these standards. For biocompatibility, typical animal testing or in-vitro tests are used, but specific numbers are not given.
- Data Provenance: The tests were conducted by the manufacturer, Hebei Hongtai Plastic Products Company Limited, in China ("Hebei Province 055250, China"). The data is retrospective as it was collected prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a Class I device like examination gloves, "ground truth" as it pertains to medical diagnosis by experts (e.g., radiologists) is not relevant. The "ground truth" for the performance of the gloves is established by the accepted scientific and engineering principles codified in the ASTM and ISO standards (e.g., a hole is a hole as defined by the test method, tensile strength is measured quantitatively). These standards are developed and agreed upon by expert committees in their respective fields (materials science, biocompatibility, etc.).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no human experts are performing diagnoses or interpretations to establish ground truth for this device, an adjudication method is irrelevant. The tests are objective, quantitative measurements against predefined 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
- No. An MRMC study is not applicable to a Class I physical device like examination gloves. These studies are typically performed for diagnostic devices (especially AI/ML-driven ones) where human performance (e.g., agreement with ground truth, detection rates) is a key outcome.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, but not in the context of an algorithm. The "standalone performance" of the gloves refers to their physical and biocompatibility characteristics when tested independently according to the specified standards. This is what the non-clinical tests (e.g., for holes, tensile strength, irritation) prove. It's the device's inherent properties, without human interpretation or intervention in its diagnostic capability because it has none.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these gloves is objective, measurable criteria defined by consensus standards:
- Physical Parameters: Measurements of length, width, thickness, tensile strength, elongation, and powder content are quantitative and directly measured by standard methods (e.g., ASTM D5250).
- Integrity: "Freedom from holes" is determined by a standardized test method (ASTM D5151) that objectively detects leaks.
- Biocompatibility: "Non-irritant" and "non-sensitizer" status is determined by standardized biological evaluation tests (ISO 10993-10), typically involving in-vitro and/or animal testing, not human expert consensus on a subjective finding.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is manufactured based on a design and then tested against standards.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding "ground truth" establishment process for this type of device.
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Image /page/0/Picture/1 description: The image shows the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2017
Hebei Hongtai Plastic Products Company Limited % Ray Wang Official Correspondent Beijing Believe Tech.service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd., Liyuan Tongzhou District Beijing, 101121 CN
Re: K163168
Trade/Device Name: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: January 14, 2017 Received: January 17, 2017
Dear Ray Wang:
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.
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
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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/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,
Michael J. Ryan -S
for Tina Kiang, Ph.D.
Acting 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) K163168
Device Name
Vinyl Examination Gloves (White) Vinyl Examination Gloves (Blue) Vinyl Examination Gloves (Yellow)
Indications for Use (Describe)
The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands 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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510(k) Summary
The assigned 510(k) Number: K163168
-
- Date of Preparation:2017/02/23
-
- Sponsor Identification
Hebei Hongtai Plastic Products Company Limited.
No. 15, Luban Road, Julu County, Xingtai, Hebei Province 055250, China Establishment Registration Number: Not yet registered
Contact Person: Liu Wei Position: General Manager Tel: +86-319-4362370 Fax: +86-319-4362371 Email: nedvidel@handform.cn
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe Tech. Service Co., Ltd
Tel: +86-18910677558, Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com
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-
- Identification of Proposed Device
Trade Name: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow): Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): XS S M L XL
- Identification of Proposed Device
Regulatory Information Classification Name: Patient Examination Glove Classification:I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
Indication for use Statement:
The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
-
- Device Description
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is available in three different colors: White, Blue, and Yellow. The proposed device was tested according to the following standards: ASTM D 6124-06, ASTM D 5151-06, ASTM D5250-06, ISO 10993-10:2010 and ISO 2859-1:2009.The proposed device is non-sterile.
- Device Description
-
- Identification of Predicate Device(s)
Predicate Device K150224 Blue Vinyl Examination Gloves Powder Free ZIBO SANYING TRADE CO., LTD
- Identification of Predicate Device(s)
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all specifications and the proposed device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves
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A ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
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ASTM D5250-06, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling > Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
- Clinical Test Conclusion 8.
No clinical study is included in this submission.
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| ITEM | Proposed Device(K163168) | Predicate Device (K150224)Blue Vinyl Examination Gloves PowderFree | Remark |
|---|---|---|---|
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Blue Vinyl Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| LabelingInformation | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Same |
9. Substantially Equivalent (SE) Comparison
Table 1 General Comparison
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| Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| Proposed Device(K163168) | Length, mm | 230 | 230 | 235 | 245 | 245 | min |
| Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm 5$ | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Predicate Device (K150224)Blue Vinyl Examination GlovesPowder Free | Designation | Size | Tolerance | ||||
| S | M | L | XL | ||||
| Length, mm | 240 | 240 | 240 | 240 | min | ||
| Width, mm | 85 | 95 | 105 | 115 | $\pm 5$ | ||
| Thickness, mm: | |||||||
| Finger | 0.10 | min | |||||
| Palm | 0.08 | min | |||||
| Remark | Analysis 1 |
Table 2 Device Dimensions Comparison
Analysis 1:
The proposed device has different size specifications as compared to the predicate device, but the proposed device meets the specifications of ASTM D5250.
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| ITEM | Proposed Device(K163168) | Predicate Device (K150224)Blue Vinyl Examination GlovesPowder Free | Remark | ||
|---|---|---|---|---|---|
| Colorant | White, Blue, Yellow | Blue | Analysis 2 | ||
| PhysicalProperties | BeforeAging | TensileStrength | 15 MPa, min | 13 MPa, min | |
| UltimateElongation | 380 % min | 400 % min | |||
| AfterAging | TensileStrength | 15 MPa, min | 13 MPa, min | Analysis 3 | |
| UltimateElongation | 380 % min | 400 % min | |||
| Comply with ASTM D5250 | Comply with ASTM D525011 MPa min./300% min. | Same | |||
| Freedom from Holes | Be free from holes when tested inaccordance with ASTM D5151AQL 1.5 | Be free from holes when testedin accordance with ASTMD5151 under AQL 2.5/InspectionLevel G-I | Same | ||
| Powder Content | 0.50 mg per glove (White)0.60 mg per glove (Blue)0.70 mg per glove (Yellow) | Meet the requirements of ASTMD5250Less than 2mg per glove | Same |
Table 3 Performance Comparison
Table 4 Safety Comparison
| ITEM | Proposed Device(K163168) | Predicate Device (K150224)Blue Vinyl Examination GlovesPowder Free | Remark | |
|---|---|---|---|---|
| Material | Vinyl | Vinyl | Same | |
| Biocompatibility | Irritation | Under the conditions of the study,not an irritant | Comply with ISO 10993-10 | Same |
| Sensitization | Under conditions of the study, not asensitizer. | Same | ||
| Label and Labeling | Meet FDA's Recommendations | Meet FDA's Recommendations | Same |
Analysis 2:
The proposed device has different colors as compared to the predicate device. This difference may cause potential biocompatibility risks. To address this concern, we evaluated the biocompatibility testing according to the standard ISO 10993-10. The results showed that the proposed devices (White, Blue, Yellow) did not induce skin irritation and skin sensitization.
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The proposed device has different Ultimate Elongation after aging as compared to the predicate device, but the proposed device meets the specifications of ASTM D5250.
-
- Substantially Equivalent (SE) Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
- Substantially Equivalent (SE) Conclusion
§ 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.