(107 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of examination gloves, with no mention of AI or ML technologies.
No
The device is a medical glove intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is a medical glove intended to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical glove made of nitrile, intended to be worn on the hand or finger. It undergoes physical and biological testing, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between the patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on physical properties, materials (nitrile), and compliance with standards related to gloves (ASTM D6319-19).
- Lack of Diagnostic Function: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
- Performance Studies: The performance studies focus on physical properties (freedom from holes, dimensions, strength) and biological safety (skin irritation, sensitization, toxicity), which are relevant to a barrier device, not a diagnostic device.
- Key Metrics: The "Not Applicable" for diagnostic metrics like sensitivity, specificity, PPV, and NPV further confirms it's not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
Medical Nitrile Examination 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
LZA
Device Description
The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in six sizes, which are XS, S, M, L, XL, XXL, 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 / Not Found
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 Test Conclusion:
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 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 10993-11:2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity;
Tests were conducted for:
- Freedom from Holes (ASTM D5151): Results showed no leakage.
- Physical dimension (ASTM D6319): Lengths met or exceeded specifications (e.g., >220mm for XS and S, >230mm for M, L, XL, XXL). Widths were within specified ranges for each size. Thickness was larger than 0.05mm.
- Physical requirement (ASTM D412): Before aging, tensile strength was larger than 14Mpa and ultimate elongation larger than 500%. After aging, tensile strength was larger than 14Mpa and ultimate elongation larger than 400%.
- Powder residue (ASTM D6214): Resulted in less than 2.0mg.
- Skin sensitization (ISO 10993-10): No skin sensitization.
- Skin irritation (ISO 10993-10): No skin irritation.
- Acute toxicity (ISO 10993-11): No acute toxicity.
Clinical Test Conclusion:
No clinical study is included in this submission.
Key Metrics
Freedom from Holes: No leakage
Physical dimension (Length): Larger than 220mm for XS and S sizes; Larger than 230mm for M, L, XL and XXL sizes.
Physical dimension (Width):
XS: within 75±5mm
S: within 85±5mm
M: within 95±5mm
L: within 115±5mm
XL: within 125±5mm
XXL: within 135±5mm
Physical dimension (Thickness): Larger than 0.05mm
Physical requirement (Before aging):
Tensile strength: Larger than 14Mpa
Ultimate elongation: Larger than 500%
Physical requirement (After aging):
Tensile strength: Larger than 14Mpa
Ultimate elongation: Larger than 400%
Powder residue: Less than 2.0mg
Skin sensitization: No skin sensitization
Skin irritation: No skin irritation
Acute toxicity: No acute 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). 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.
October 13, 2021
Jiangxi Ronglai Medical Technology Co., Ltd. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O.box 120-119 Shanghai. 200120 China
Re: K212014
Trade/Device Name: Medical Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 9, 2021 Received: September 14, 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 (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
Indications for Use
510(k) Number (if known)
Device Name Medical Nitrile Examination Gloves
Indications for Use (Describe)
Medical Nitrile Examination 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: K212014
-
- Date of Preparation: 10/13/2021
-
- Sponsor Identification
Jiangxi Ronglai Medical Technology Co., Ltd. NO.666 Baixu Street, Baixu town, Jinxian County, Nanchang City, Jiangxi Province, China
Establishment Registration Number: 3016681386
Contact Person: Hailin Shu Position: Manager Tel: +86-13870683591 Email: 910604423@qq.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
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: Medical Nitrile Examination Gloves Common Name: POWDER FREE NITRILE EXAMINATION GLOVES
Regulatory Information
Classification Name: polymer patient examination glove Classification: I; Product Code: LZA; Regulation Number: 21CFR 880.6250 Review Panel: General Hospital;
Indication for Use:
Medical Nitrile Examination 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 blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in six sizes, which are XS, S, M, L, XL, XXL, 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.
-
- Identification of Predicate Device
510(k) Number: K172015
Product Name: Powder Free Nitrile Examination Gloves, Blue (colored)
- Summary of Technological characteristics 6.
| ITEM | Proposed Device | Predicate Device
K172015 | Remark |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indication for use | Medical Nitrile Examination 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. | A 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 |
Table 1 Comparison of Technology Characteristics
5
| Material | Nitrile | Nitrile | Same | ||
|---|---|---|---|---|---|
| Color | Blue | Blue | Same | ||
| Sterility | Non-sterile | Non-sterile | Same | ||
| Single-use | Yes | Yes | Same | ||
| Size | XS, S, M, L, XL, XXL | XS, S, M, L, XL | |||
| Width | |||||
| XS | 75 ± 5mm | XS | 70 ± 10mm | Different | |
| S | 85 ± 5mm | S | 80 ± 10mm | ||
| M | 95 ± 5mm | M | 95 ± 10mm | ||
| L | 115 ± 5mm | L | 110 ± 10mm | ||
| XL | 125 ± 5mm | XL | 120 ± 10mm | ||
| XXL | 135 ± 5mm | / | |||
| Length | |||||
| Dimensions | |||||
| (ASTM D6319-19) | XS | >220mm | XS | 220mm min | |
| S | >230mm | S | 220mm min | ||
| M | ≥240mm | M | 230mm min | ||
| L | ≥250mm | L | 230mm min | ||
| XL | >250mm | XL | 230mm min | ||
| XXL | ≥260mm | / | |||
| Thickness | |||||
| Palm | >0.05mm | Palm | 0.05mm min | ||
| Finger | >0.05mm | Finger | 0.05mm min | ||
| Before Aging | |||||
| Physical | |||||
| Properties | |||||
| (ASTM | |||||
| D6319-19 | |||||
| and | |||||
| ASTM | |||||
| D412-16) | Tensile Strength | 14MPa min | Tensile Strength | 14MPa min | Same |
| Ultimate Elongation | 500% min | Ultimate Elongation | 500% min | ||
| After Aging | |||||
| Tensile Strength | 14MPa min | Tensile Strength | 14MPa min | ||
| Ultimate Elongation | 400% min | Ultimate Elongation | 400% min | ||
| Powder | |||||
| free | |||||
| residue | |||||
| (ASTM | |||||
| D6319-19 | |||||
| and | |||||
| ASTM D6124-06) | Less than 2mg per glove | Less than 2mg per glove | Same | ||
| Freedom | |||||
| from | |||||
| Holes | |||||
| (ASTM | |||||
| D5151-19) | Meet AQL 2.5 | Before aging: Meet AQL 1.5 | |||
| After aging: Meet AQL 2.5 | Different | ||||
| Biocompatibility | |||||
| Skin Irritation | ISO 10993-10, Under the condition | No Irritation | |||
| of study, not an irritant. | |||||
| Sensitization | ISO 10993-10, Under the condition | No Sensitization | Different | ||
| of study, not a sensitizer | |||||
| System Toxicity | ISO 10993-11, Under the condition | / | |||
| of the study, the device extract does |
6
| not pose a systemic toxicity concern. | ||
|---|---|---|
| -- | --------------------------------------- | -- |
Different- Size& Dimensions
The size and dimension of the proposed device is not exactly same as the predicate device. However, the size and dimension of the proposed device has been covered by ASTM D6319-19. The user can select appropriate model depended on size of user's hand. In addition, its dimension has been tested and meet the requirement of ASTM D6319-19. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Different-Freedom from holes
The adopted AQL for the proposed device is different from predicate device. However, the adopted AQL was same as the requirement of ASTM D6319 standard. Therefore, this AQL is acceptable and it can be considered that this the difference will not affect the safety and effectiveness of the proposed device.
Different- Biocompatibility
The biocompatibility test item of the proposed device is different from the predicate device. However, more biocompatibility tests have been performed on the proposed device than the predicate device and the all test results show the material of the proposed device has no toxicity. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
7. Non-Clinical Test Conclusion
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 D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
- A 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 A Skin Sensitization;
-
ISO 10993-11:2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity;
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Freedom from | |||
| Holes-ASTM D5151 | Detection the holes | ||
| that allow water | |||
| leakage | Do not show droplet, | ||
| stream or other type of | |||
| water leakage | No leakage | ||
| Physical | Evaluate the glove | Length: >220 mm (XS | Length |
7
| dimension-ASTM D6319 | physical dimension | ||
|---|---|---|---|
| and S sizes) | |||
| Length: > 230 mm (M, L, XL and XXL sizes) | |||
| Width (±10mm) | |||
| XS = 70mm | |||
| S = 80mm | |||
| M = 95mm | |||
| L = 110mm | |||
| XL = 120mm | |||
| XXL=130mm | |||
| Thickness at Finger (mm) | |||
| All Sizes ≥ 0.05 mm | |||
| Thickness at Palm | |||
| All Sizes ≥ 0.05 mm | Larger than 220mm for XS and S size | ||
| Larger than 230mm for M, L, XL and XXL sizes | |||
| Width | |||
| XS: within 75±5mm | |||
| S: within 85±5mm | |||
| M: within 95±5mm | |||
| L: within 115±5mm | |||
| XL: within 125±5mm | |||
| XXL: within 135±5mm | |||
| Thickness | |||
| Larger than 0.05mm | |||
| Physical | |||
| requirement-ASTM D412 | Evaluate the physical | ||
| requirement | Before Aging (Min) | ||
| Tensile strength: | |||
| 14Mpa | |||
| Ultimate elongation: | |||
| 500% | |||
| After Aging (Min) | |||
| Tensile strength: | |||
| 14Mpa | |||
| Ultimate elongation: | |||
| 400% | Before aging | ||
| Larger than 14Mpa and | |||
| 500% | |||
| After aging | |||
| Larger than 14Mpa and | |||
| 400% | |||
| Powder residue-ASTM | |||
| D6214 | Evaluate the residue | ||
| powder | Less than 2.0mg | Less than 2.0mg | |
| Skin sensitization-ISO | |||
| 10993-10 | Evaluated for the | ||
| potential to cause | |||
| delayed dermal | |||
| contact sensitization | Non-sensitizing | No skin sensitization | |
| Skin irritation-ISO | |||
| 10993-10 | Evaluated for the | ||
| potential to cause skin | |||
| irritation | Non-irritating | No skin irritation | |
| Acute toxicity-ISO | |||
| 10993-11 | Evaluated for acute | ||
| systemic toxicity | Non-acute systemic | ||
| toxic | No acute toxicity |
8
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. 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 K172015.