(107 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of vinyl exam gloves, with no mention of AI or ML technologies.
No.
The device, Vinyl Exam Gloves, is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device, vinyl exam gloves, is intended to prevent contamination between the patient and examiner. Its function is protective, not to diagnose any medical condition. The performance studies focus on physical properties and biocompatibility, not diagnostic metrics.
No
The device description clearly states it is a physical product (gloves) made of Poly (vinyl chloride) and describes physical characteristics and performance tests related to material properties and biocompatibility, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and materials of the glove, not on any components or functionalities related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Calibration or quality control procedures for diagnostic testing
The device described is a medical device, specifically a medical glove, intended for barrier protection during medical examinations. It falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Vinyl Exam 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.
Product codes
LYZ
Device Description
The proposed device is a powder free medical glove. The device is available in transparent. The device meets the requirements of ASTM D5250-19: Standard specification for Poly (vinyl chloride) Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ASTM D5250-19 Standard specification for Poly (vinyl chloride) Gloves for Medical Application
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
- ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity
Study: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization (ISO 10993-10:2010). Purpose: Evaluated for the potential to cause delayed dermal contact sensitization and skin irritation. Acceptance Criteria: Magnusson and Kligman grade shall be less than control group, No significant reaction than the control group. Test Results: No skin sensitization, No skin irritation.
Study: Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity (ISO 10993-5:2009). Purpose: Evaluated for the potential cytotoxicity. Acceptance Criteria: The viability shall be not reduced to less than 70%. Test Results: No cytotoxic.
Study: Standard Test Method for Residual Powder on Medical Gloves (ASTM D6124-06 (Reapproved 2017)). Purpose: Evaluate the residue powder. Acceptance Criteria: Less than 2.0mg. Test Results: Less than 2.0mg.
Study: Standard Test Method for Detection of Holes in Medical Gloves (ASTM D5151-06(Reapproved 2015)). Purpose: Detection the holes that allow water leakage. Acceptance Criteria: Do not show droplet, stream or other type of water leakage. Test Results: No leakage.
Study: Standard Specification for Nitrile Examination Gloves for Medical Application (ASTM D6319-10 (Reapproved 2015)). Purpose: Evaluate the glove physical dimension. Acceptance Criteria: Length: > 230 mm, Width (±5mm) XS = 75mm, S = 85mm, M = 95mm, L = 105mm, XL = 115mm, Thickness at Finger (mm) All Sizes ≥ 0.08 mm, Thickness at Palm All Sizes ≥ 0.08 mm. Test Results: Length Larger than 230mm, Width XS: within 75±5mm S: within 85±5mm M: within 95±5mm L: within 105±5mm XL: within 115±5mm, Thickness Larger than 0.08mm.
Study: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension (ASTM 412-16). Purpose: Evaluate the physical requirement. Acceptance Criteria: Tensile strength: 11Mpa, Ultimate elongation: 300%. Test Results: Larger than 11Mpa and 300%.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 5, 2022
Hebei Astro Medical Supply Co., Ltd Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K213019
Trade/Device Name: Vinyl Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: November 26, 2021 Received: December 8, 2021
Dear Diana Hong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213019
Device Name Vinyl Exam Gloves
Indications for Use (Describe)
Vinyl Exam 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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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K213019
1. Date of Preparation: 01/03/2022
2. Sponsor Identification
Hebei Astro Medical Supply Co., Ltd
East of Xiaoxixian, West of Jingsan Street, South of Weiwu Road, North of Weiqi Road, Jinzhou Economic Development Zone, Hebei Province, P.R.China, 052260
Establishment Registration Number: 3015537296
Contact Person: Ning Zheng Position: General Manager Tel: +86-18617965639 Fax: +86-311-85125615 Email: erin@wallyplastic.net
3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-2281-5850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Vinyl Exam Gloves Common Name: Examination Vinyl Gloves
Regulatory Information
Classification Name: Vinyl Patient Examination Glove Classification: I; Product Code: LYZ; Regulation Number: 21CFR 880.6250 Review Panel: General Hospital;
Indication for Use:
Vinyl Exam 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.
Device Description
The proposed device is a powder free medical glove. The device is available in transparent. The device meets the requirements of ASTM D5250-19: Standard specification for Poly (vinyl chloride) Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
ડ. Identification of Predicate Device
510(k) Number: K210799 Product Name: Powder Free Vinyl Patient Examination Glove
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ASTM D5250-19 Standard specification for Poly (vinyl chloride) Gloves for Medical Application
-
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
-
ASTM D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
-
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
5
-
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
-
ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity ;
- Summary of Technological characteristics 7.
| Table 1 Comparison of Technology Characteristics | ||||
|---|---|---|---|---|
| ITEM | Proposed Device | |||
| K213019 | Predicate Device | |||
| K210799 | Remark | |||
| Product Code | LYZ | LYZ | Same | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | |
| Class | I | I | Same | |
| Indication for use | Vinyl Exam 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. | The Powder Free 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. | Same | |||
| Material | Vinyl | Vinyl | Same | |
| Color | Clear | Clear | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Single-use | Yes | Yes | Same | |
| Size | XS, S, M, L, XL | XS, S, M, L, XL | Same | |
| Dimensions | ||||
| (ASTM D5250-19) | Width | |||
| XS | $75 \pm 5mm$ | XS | $75 \pm 5mm$ | |
| S | $85 \pm 5mm$ | S | $85 \pm 5mm$ | |
| M | $95 \pm 5mm$ | M | $95 \pm 5mm$ | |
| L | $105 \pm 5mm$ | L | $105 \pm 5mm$ | |
| Length | Same | |||
| XS | 230mm min | XS | 230mm min | |
| S | 230mm min | S | 230mm min | |
| M | 230mm min | M | 230mm min | |
| L | 230mm min | L | 230mm min | |
| XL | 230mm min | XL | 230mm min | |
| Thickness |
Table 1 Comparison of Technology Characteristics
6
| Palm | 0.08mm min | Palm | 0.08mm min | |||
|---|---|---|---|---|---|---|
| Finger | 0.08mm min | Finger | 0.08mm min | |||
| Before Aging | ||||||
| Physical Properties | ||||||
| (ASTM D5250-19 | ||||||
| and ASTM | ||||||
| D412-16) | Tensile Strength | 11MPa min | Tensile Strength | 11MPa min | Same | |
| Ultimate Elongation | 300% min | Ultimate Elongation | 300% min | |||
| After Aging | ||||||
| Tensile Strength | 11MPa min | Tensile Strength | 11MPa min | |||
| Ultimate Elongation | 300% min | Ultimate Elongation | 300% min | |||
| Power free residue | ||||||
| (ASTM D6124-06) | Less than 2mg per glove | Less than 2mg per glove | Same | |||
| Freedom from | ||||||
| Holes (ASTM | ||||||
| D5151-19) | No water leakage occurs. | No water leakage occurs. | Same | |||
| Biocompatibility | ||||||
| Skin Irritation | Under the conditions of the study, not an Irritant | Under the conditions of the study, not an Irritant | ||||
| Sensitization | Under the conditions of the study, not a Sensitization | Under the conditions of the study, not a Sensitization | Same | |||
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic. | Under the conditions of the study, the device is non-cytotoxic. |
8. Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
| No. | Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Test Results |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization | Evaluated for the potential to cause delayed dermal contact sensitization and skin irritation | Magnusson and Kligman grade shall be less than control group | |
| No significant reaction than the control group | No skin sensitization | |||
| No skin irritation | ||||
| 2 | ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity | Evaluated for the potential cytotoxicity | The viability shall be not reduced to less than 70% | No cytotoxic |
| 3 | ASTM D6124-06 (Reapproved | Evaluate the | Less than 2.0mg | Less than 2.0mg |
Table 2. Summary of Non-Clinical Performance Testing
7
| | 2017), Standard Test Method for
Residual Powder on Medical
Gloves | residue powder | | |
|---|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4 | ASTM D5151-06(Reapproved
2015), Standard Test Method for
Detection of Holes in Medical
Gloves. | Detection the
holes that allow
water leakage | Do not show droplet,
stream or other type of
water leakage | No leakage |
| 5 | ASTM D6319-10 (Reapproved
2015), Standard Specification for
Nitrile Examination Gloves for
Medical Application. | Evaluate the
glove physical
dimension | Length: > 230 mm
Width (±5mm)
XS = 75mm
S = 85mm
M = 95mm
L = 105mm
XL = 115mm
Thickness at Finger
(mm)
All Sizes ≥ 0.08 mm
Thickness at Palm
All Sizes ≥ 0.08 mm | Length
Larger than 230mm
Width
XS: within 75±5mm
S: within 85±5mm
M: within 95±5mm
L: within 105±5mm
XL: within 115±5mm
Thickness
Larger than 0.08mm |
| 6 | ASTM 412-16 Standard Test
Methods for Vulcanized Rubber
and Thermoplastic
Elastomers-Tension | Evaluate the
physical
requirement | Tensile strength: 11Mpa
Ultimate elongation:
300% | Larger than 11Mpa and
300% |
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device K210799.