(84 days)
Not Found
No
The device is a simple physical barrier (gloves) and the summary contains no mention of AI, ML, image processing, or data analysis beyond standard physical property testing.
No
The device, Nitrile Examination Gloves, is intended to prevent contamination and protect the wearer and patient, not to treat or cure a disease or condition.
No
The device is a glove, used for preventing contamination between patient and examiner, not for diagnosing any condition.
No
The device is a physical product (gloves) and does not involve any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device's Intended Use: The intended use of these nitrile examination gloves is to be worn on the examiner's hands to prevent contamination between the patient and the examiner. This is a barrier device used during a medical procedure or examination, not for testing specimens.
- Device Description: The description focuses on the physical characteristics and materials of the glove, not on any diagnostic testing capabilities.
- Lack of IVD-related information: The document does not mention any aspects related to specimen collection, analysis, reagents, or diagnostic results, which are typical for IVD devices.
Therefore, based on the provided information, the Nitrile Examination Gloves are a medical device used for barrier protection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nitrile Examination Gloves (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The proposed device, Nitrile Examination Gloves (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.
The proposed device is provided non-sterile. The proposed device is made of Nitrile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
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)
Bench 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:
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-17, 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 Performance Test Results:
- ASTM D5151 (Testing for Freedom from holes): No water leakage is inspected from 200 samples.
- ASTM D6124 (Determine the powder residue for powder free gloves): Residual Powder of Size XS: Average 0.28 mg; Residual Powder of Size S: Average 0.31 mg; Residual Powder of Size M: Average 0.34 mg; Residual Powder of Size L: Average 0.31 mg; Residual Powder of Size XL: Average 0.40 mg.
- ASTM D412, ASTM D573 (Testing for Physical property characteristics): Before Aging: Tensile Strength: ≥ 19MPa; Ultimate Elongation: ≥ 500%. After Aging: Tensile Strength: ≥ 18 MPa; Ultimate Elongation: ≥ 473%.
- ASTM D412, ASTM D3767 (Testing For physical dimensions specification): Length of Size XS: ≥ 223 mm; Width of Size XS: 75±2 (73-77) mm; Cuff Thickness of Size XS: ≥0.06 mm; Palm Thickness of Size XS: ≥0.07 mm; Finger Thickness of Size XS: ≥0.10 mm. Length of Size S: ≥ 224mm; Width of Size S: 85±2 (85-87) mm; Cuff Thickness of Size S: ≥0.06 mm; Palm Thickness of Size S: ≥0.07 mm; Finger Thickness of Size S: ≥0.10 mm. Length of Size M: ≥ 233 mm; Width of Size M: 95±3 (95-98) mm; Cuff Thickness of Size M: ≥0.06 mm; Palm Thickness of Size M: ≥0.07 mm; Finger Thickness of Size M: ≥0.10 mm. Length of Size L: ≥ 236mm; Width of Size L: 115±4 (115-119) mm; Cuff Thickness of Size L: ≥0.06 mm; Palm Thickness of Size L: ≥0.07 mm; Finger Thickness of Size L: ≥0.10 mm. Length of Size XL: ≥ 236 mm; Width of Size XL: 125±2 (115-117) mm; Cuff Thickness of Size XL: ≥0.06 mm; Palm Thickness of Size XL: ≥0.07 mm; Finger Thickness of Size XL: ≥0.10 mm.
- ISO 10993-5 (Evaluate the endpoint of Cytotoxicity for biocompatibility): The test article showed no evidence of systemic toxicity from the extract.
- ISO 10993-10 (Evaluate the endpoint of irritant for biocompatibility): The test article showed no irritation on the skin.
- ISO 10993-10 (Evaluate the endpoint of sensitization for biocompatibility): The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
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 contains the logo of the U.S. Food & 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.
December 14, 2021
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K213029
Trade/Device Name: Nitrile Examination Gloves (Powder free, Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 21, 2021 Received: September 21, 2021
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. 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 (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, PhD 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) K213029
Device Name
Nitrile Examination Gloves (Powder free, Blue)
Indications for Use (Describe)
The Nitrile Examination Gloves (Powder free, Blue) 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)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K213029
-
- Date of Preparation: 11/23/2021
-
- Sponsor
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
No.567, Gushan Road, Area of Economy and Technique,264207, Weihai City, Shandong Province, P.R. China. Contact Person: Dong Bin Position: General Manager Tel: +86-15662383633 Fax: +86-631-3636942 Email: dbfeel@163.com
-
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
- Proposed Device Identification 4.
Trade Name: Nitrile Examination Gloves (Powder free, Blue) Common Name: NITRILE Patient Examination Gloves (Powder Free) Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250
4
Review Panel: General Hospital
Indication For Use Statement:
The Nitrile Examination Gloves (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
- Predicate Device Identification 5.
510(k) Number: K150340
Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD
- Device Description 6.
The proposed device, Nitrile Examination Gloves (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.
The proposed device is provided non-sterile. The proposed device is made of Nitrile.
| Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|
| XS | S | M | L | XL | ||
| Length, mm | 220 | 220 | 230 | 235 | 235 | min |
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| Thickness, mm: | ||||||
| Finger | 0.05 | min | ||||
| Palm | 0.05 | min | ||||
| Cuff | 0.05 | min |
Table 1 Device Size Specifications
| Table 2 Performance and Physical Specifications | |
|---|---|
| ------------------------------------------------- | -- |
| Before Aging | After Aging | Pinhole AQL | ||
|---|---|---|---|---|
| Tensile | ||||
| Strength | Ultimate | |||
| Elongation | Tensile | |||
| Strength | Ultimate | |||
| Elongation | 2.5 | |||
| 14 MPa, min | 500 % min | 14 MPa, min | 400 % min |
5
The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319.
Comparison of Technological Characteristics 7.
| ITEM | Proposed Device(K213029) | Predicate Device (K150340) | Remark |
|---|---|---|---|
| Nitrile Examination Gloves (Powder free, | |||
| Blue) | POWDER FREE Nitrile GLOVES (White, | ||
| Cobalt Blue, Black, Ice Blue) | |||
| Product Code | LZA | LZA | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use | The Nitrile Examination Gloves (Powder | ||
| free, Blue) is a disposable device intended | |||
| for medical purposes that is worn on the | |||
| examiner's hands to prevent contamination | |||
| between patient and examiner. | The POWDER FREE Nitrile GLOVES | ||
| (White, Cobalt Blue, Black, Ice Blue) is a | |||
| disposable device intended for medical | |||
| purposes that is worn on the examiner's | |||
| hands to prevent contamination between | |||
| patient and examiner. | SAME | ||
| Powdered or | |||
| Powered free | Powdered free | Powdered free | SAME |
Table 1 General Comparison
6
| Proposed Device(K213029) | Size | |||||||
|---|---|---|---|---|---|---|---|---|
| Nitrile Examination Gloves | ||||||||
| (Powder free, Blue) | Designation | XS | S | M | L | XL | Tolerance | |
| Length, mm | 220 | 220 | 230 | 235 | 235 | min | ||
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Cuff | 0.05 | min | ||||||
| Predicate Device (K150340) | Size | |||||||
| POWDER FREE Nitrile | ||||||||
| GLOVES (White, Cobalt Blue, | ||||||||
| Black, Ice Blue) | Designation | XS | S | M | L | XL | Tolerance | |
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | ||
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | ||||||||
| Finger | 0.10-0.12 | ±0.03 | ||||||
| Palm | 0.08-0.10 | ±0.03 | ||||||
| Cuff | 0.06-0.09 | ±0.03 | ||||||
| Remark | Similar |
Table 2 Device Dimensions Comparison
Different Analysis:
The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 6319.
So we consider this as the proposed device is similar to the predicate device.
| ITEM | Proposed Device(K213029)
Nitrile Examination Gloves
(Powder free, Blue) | Predicate Device (K150340)
POWDER FREE Nitrile GLOVES
(White, Cobalt Blue, Black, Ice
Blue) | Remark | | |
|------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------|-------------|-----------|
| Colorant | Blue | White, Cobalt Blue, Black, Ice Blue | Different | | |
| Single Use | Yes | Yes | SAME | | |
| Physical
Properties | Before
Aging | Tensile Strength | 14 MPa, min | 15 MPa, min | Different |
| | Ultimate
Elongation | 500 % min | 500 % min | SAME | |
| | After
Aging | Tensile
Strength | 14 MPa, min | 14 MPa, min | SAME |
Table 3 Performance Comparison
7
| | | Ultimate
Elongation | 400 % min | 400 % min | SAME |
|--------------------|--|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------|------|
| | | Comply with ASTM D6319 | Comply with ASTM D6319 | SAME | |
| Freedom from Holes | | Be free from holes when tested in
accordance with ASTM D5151,
AQL 2.5 | Be free from holes when tested in
accordance with ASTM D5151,
AQL 1.5 | Different | |
| | | | | | |
| Powder Content | | Less than 2 mg per glove when tested
in accordance with ASTM D6124 | Meet the requirements of ASTM
6124 | SAME | |
| | | | | | |
Different Analysis:
The proposed device has different color to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-5, and ISO 10993-10 the test results showed that the proposed devices with blue colorant did not induce skin irritation and showed no significant evidence of causing skin sensitization and no cytotoxic potential.
Different Analysis:
The proposed device has different Tensile Strength before aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.
Different Analysis:
The proposed device has different AQL to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.
| ITEM | | Proposed Device (K213029)
Nitrile Examination Gloves
(Powder free, Blue) | Predicate Device (K150340)
POWDER FREE Nitrile GLOVES
(White, Cobalt Blue, Black, Ice
Blue) | Remark |
|--------------------|---------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------|
| Material | | Nitrile | Nitrile | SAME |
| Biocompatibility | Irritation | Under the conditions of the study,
not an irritant | Under the conditions of the study,
not an irritant | SAME |
| | Sensitization | Under conditions of the study, not a
sensitizer. | Under conditions of the study, not a
sensitizer. | SAME |
| | Cytotoxic | Under the conditions of the study,
there was no evidence of cytotoxic
potential from the extract. | Not Available | Different |
| Label and Labeling | | Meet FDA's Requirements | Meet FDA's Requirements | SAME |
Table 4 Safety Comparison
Different Analysis:
The proposed device has conducted the acute cytotoxic testing, and the test results shown that there was
8
no evidence of cytotoxic potential.
8. Summary of Non-Clinical Testing
Bench 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:
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-17, 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.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom | ||
| from holes | Freedom from holes | ||
| AQL 2.5 | No water leakage is inspected form 200 samples | ||
| ASTM D6124 | Determine the powder | ||
| residue for powder free | |||
| gloves |