(244 days)
Not Found
No
The device is a disposable examination glove, and the description focuses on its physical properties and performance characteristics according to established standards. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device, examination gloves, is intended to prevent contamination between the patient and examiner, not to provide therapy or treatment.
No
Explanation: The device described is an examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function. Its characteristics relate to physical properties and safety, not the detection or diagnosis of diseases or conditions.
No
The device is a physical examination glove made of vinyl and nitrile rubber, not software. The description details material composition, physical characteristics, and performance testing related to a tangible product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, 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 characteristics and materials of examination gloves.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
- Performance Studies: The performance studies focus on the physical and biological safety of the gloves (tensile strength, freedom from holes, biocompatibility), not on the accuracy or reliability of diagnostic measurements.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. Examination gloves serve a different purpose – to protect both the patient and the examiner from contamination during physical contact.
N/A
Intended Use / Indications for Use
Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Nitrile Vinyl Blend Powder Free Examination Gloves (Black) are Patient Examination Gloves. Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L and XL. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- 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
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Key Metrics
- Length: All size: Minimum 230mm (XS: 230-245mm, S: 230-245mm, M: 230-245mm, L: 230-245mm, XL: 230-247 mm)
- Palm Width: XS: 70±10mm (76-78mm), S: 80±10mm (86-88 mm), M:95±10mm (96 -98mm), L:110±10mm (106-110 mm), XL: 120±10mm (116-118 mm)
- Thickness: Finger: Minimum 0.05mm (0.06-0.08mm), Palm: Minimum 0.05mm (0.07-0.09mm)
- Tensile Strength, Before Aging: 14MPa, min (14.2-16.9 MPa)
- Tensile Strength, After Accelerated Aging: 14MPa, min (14.1-16.2MPa)
- Ultimate Elongation, Before Aging: 500%, min (500-520%)
- Ultimate Elongation, After Accelerated Aging: 400%, min (400-480%)
- Freedom from holes: G-I, AQL 2.5 (XS: 0/125, S:0/125, M: 0/125, L:1/125, XL: 1/125)
- Powder-Content: ≤ 2 mg per glove (XS:0.35mg, S: 0.41mg, M: 0.47mg, L: 0.55mg, XL: 066mg)
- Skin Irritation Study: Under the conditions of the study, not an irritant
- Maximization Sensitization Study: Under the conditions of the study, not a sensitizer
- Cytotoxicity Test: Under the conditions of this study, the test article extract showed potential toxicity
- Systemic toxicity: Under the conditions of this study, there was no evidence of systemic toxicity.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 12, 2022
Grand Work Plastic Products Co., Ltd Donggao Industrial Zone, Zanhuang, Hebei 050000, China % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K213574
Trade/Device Name: Nitrile Vinyl Blend Powder Free Examination Gloves (Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 14, 2022 Received: June 16, 2022
Dear Kathy Liu:
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.
1
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 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 medical devices and radiation-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.
Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213574
Device Name
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
Indications for Use (Describe)
Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is a disposable device intended for medical purposes that is worn on the examiner's hand 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
K213574
Product: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) number is: K213574
Date Prepared: July 12, 2022
1. Owner's Identification:
Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611
2. Name of the Device:
Trade Name: Nitrile Vinyl Blend Powder Free Examination Gloves (Black) Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA Device Class: Class I
3. Predicate Device Information:
Grand Work Plastic Products Co., Ltd. Vinyl Nitrile Co-Polymer Powder Free Examination Gloves (Blue)- (K051662)
4. Device Description:
Nitrile Vinvl Blend Powder Free Examination Gloves (Black) are Patient Examination Gloves. Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L and XL. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
5. Intended Use of the Device:
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6. Comparison of Subject Device and Predicate Device:
Grand Work Plastic Products Co. Ltd.'s Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is safety and effectiveness as the Grand Work Plastic Products Co., Ltd.'s Vinyl Nitrile Co-Polymer Powder Free Examination Gloves (Blue)- (K051662). The subject device and predicate
4
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
device use a similar plastic flexible barrier film to achieve a device for the intended use. And the properties between the subject device and the predicate device are compared in the following table:
| # | Proposed Device
K213574 | Predicate Device
K051662 | Remark |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Trade Name | Nitrile Vinyl Blend Powder Free
Examination Gloves (Black) | Vinyl Nitrile Co-
Polymer Powder Free
Examination Gloves
(Blue) | Similar |
| Product Code | LZA | LZA | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Nitrile Vinyl Blend Powder Free
Examination Gloves (Black) is a
disposable device intended for
medical purposes that is worn on the
examiner's hand to prevent
contamination between patient and
examiner. | Vinyl Nitrile Co-
Polymer Powder Free
Examination Gloves
(Blue) is a disposable
device intended for
medical purposes that is
worn on the examiner's
hand to prevent
contamination between
patient and examiner. | Same |
| Powder or Powder
Free | Powder Free | Powder Free | Same |
| Materials | vinyl and oil-based liquid nitrile
rubber | vinyl and oil-based
liquid nitrile rubber | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Black | Blue | Different |
| Labeling Information | Single-use, powder free glove size, quantity, Examination Gloves, Non
Sterile | Single-use, powder free
glove size, quantity,
Examination Gloves,
Non Sterile | Same |
General Comparison Table:
Dimensions and Performance Comparison Table:
| Technological
| Characteristics | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Length | Minimum 230mm | Minimum 230mm | Same |
| Palm Width (size) (mm) | |||
| XS | $70\u00b110$ | $70\u00b110$ | Same |
| S | $80\u00b110$ | $80\u00b110$ | Same |
| M | $95\u00b110$ | $95\u00b110$ | Same |
5
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| L | 110±10 | 110±10 | Same |
|---|---|---|---|
| XL | 120±10 | 120±10 | Same |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before | |||
| Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, | |||
| Before Aging | 500%, min | 500%, min | Same |
| Tensile Strength, After | |||
| Accelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, After | |||
| Accelerated Aging | 400%, min | 400%, min | Same |
| Freedom from holes | In accordance with ASTM D 5151-19, | ||
| following ASTM D6319-19, G-I, AQL 2.5 | In accordance with ASTM D 5151-19, | ||
| following ASTM D6319-19, G-I, AQL 2.5 | Same | ||
| Powder-Content | ≤2 mg per glove | ≤2 mg per glove | Same |
| 10993-10:2010 Skin | |||
| Irritation Study | Under the conditions of the | ||
| study, | |||
| not an irritant | Under the conditions of the | ||
| study, | |||
| not an irritant | Same | ||
| 10993-10:2010 | |||
| Maximization | |||
| Sensitization Study | Under the conditions of the | ||
| study, | |||
| not a sensitizer | Under the conditions of the | ||
| study, | |||
| not a sensitizer | Same | ||
| 10993-5:2009 In Vitro | |||
| Cytotoxicity Test | Under the conditions of this | ||
| study, the test article extract | |||
| showed potential toxicity | / | Exceed | |
| ISO 10993 Part 11 | |||
| Acute Systemic Toxicity | |||
| Test | Under the conditions of this | ||
| study, there was no evidence | |||
| of systemic toxicity. | / | Exceed |
Product: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
Grand Work Plastic Products Co., Ltd.'s Nitrile Vinyl Blend Powder Free Examination Gloves (Black) shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D6319-19, biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.
7. Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And ● Skin Sensitization.
6
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro . Cytotoxicity
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity ●
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical ● Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ●
- ●
| Test method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Length | All size: | |
| Minimum 230mm | XS: 230-245mm | ||
| S: 230-245mm | |||
| M: 230-245mm | |||
| L: 230-245mm | |||
| XL: 230-247 mm | |||
| ASTM D6319- 19 | Palm Width | XS: 70±10mm | 76-78mm |
| S: 80±10mm | 86-88 mm | ||
| M:95±10mm | 96 -98mm | ||
| L:110±10mm | 106-110 mm | ||
| XL: 120±10mm | 116-118 mm | ||
| ASTM D6319- 19 | Thickness | Finger: 0.05mm (min) | 0.06-0.08mm |
| Palm: 0.05mm (min) | 0.07-0.09mm | ||
| ASTM D6319-19 | |||
| ASTN D412-16 | Tensile Strength, Before | ||
| Aging | 14MPa, min | 14.2-16.9 MPa | |
| ASTM D6319-19 | |||
| ASTN D412-16 | Tensile Strength, After | ||
| Accelerated Aging | 14MPa, min | 14.1-16.2MPa | |
| ASTM D6319-19 | |||
| ASTN D412-16 | Ultimate Elongation, | ||
| Before Aging | 500%, min | 500-520% | |
| ASTM D6319-19 | |||
| ASTN D412-16 | Ultimate Elongation, After | ||
| Accelerated Aging | 400%, min | 400-480% | |
| ASTM D 5151-19 | |||
| ASTM D6319- 19 | Freedom from holes | G-I, AQL 2.5 | XS: 0/125 |
| S:0/125 | |||
| M: 0/125 | |||
| L:1/125 | |||
| XL: 1/125 | |||
| ASTM D 6124-06(2017) | |||
| ASTM D6319- 19 | Powder-Content | ≤ 2 mg per glove | XS:0.35mg |
| S: 0.41mg | |||
| M: 0.47mg | |||
| L: 0.55mg |
7
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| XL: 066mg | |||
|---|---|---|---|
| ISO 10993-10:2010 | Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
| ISO 10993-10:2010 | Maximization | ||
| Sensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | |
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of this study, the test article extract showed potential toxicity | Under the conditions of this study, the test article extract showed potential toxicity |
| ISO 10993-11:2017 | Systemic toxicity | Under the conditions of this study, there was no evidence of systemic toxicity. | Under the conditions of this study, there was no evidence of systemic toxicity. |
Product: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
8. Clinical Performance Data
N/A
9. 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 predicated device.