(95 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device, a nitrile examination glove, is intended to prevent contamination between the patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device is described as a "disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner." This function is protective and preventative, not diagnostic.
No
The device description clearly states it is a physical product (nitrile examination gloves) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
- Device Intended Use: The intended use of this device is clearly stated as "A disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner." This is a barrier device used for infection control.
- Device Description: The description details a physical barrier (nitrile gloves) and its properties, not a test or analysis of a biological sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection of specific analytes (proteins, DNA, antibodies, etc.)
- Use of reagents or assays
- Diagnostic or screening purposes
The device is a medical device, specifically a Class I or Class II medical device (depending on the regulatory jurisdiction and specific claims), but it falls under the category of personal protective equipment (PPE) used in a medical setting, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
A disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is NBR BLUE 7214 (which composed of Phthalocyanine blue (CAS No.147-14-8) and Propylene glycol (CAS No.57-55-6). The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.
The examination gloves meet the specifications in 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 or fingers
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Physical Dimensions Test (ASMT D6319-19):
- Test Purpose: To determine the width, length, and thickness of the gloves.
- Acceptance Criteria: Width: For M: 95 ± 10mm, For L: 110 ± 10mm, For XL: 120 ± 10mm. Length: For M: ≥230mm, For L: ≥230mm, For XL: ≥230mm. Thickness: Finger: ≥0.05mm, Palm: ≥0.05mm.
- Test Results: For M: Width: 93
96mm, Length: 236239mm, Finger: 0.060.09mm, Palm: 0.060.08mm. For L: Width: 104-107mm, Length: 236239mm, Finger: 0.060.08mm, Palm: 0.060.08mm. For XL: Width: 112116mm, Length: 255258mm, Finger: 0.080.10mm, Palm: 0.06~0.09mm. - Conclusion: Passed.
- Physical Properties Test (ASMT D6319-19):
- Test Purpose: To determine the tensile strength and ultimate elongation before and after acceleration aging.
- Acceptance Criteria: Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500%. After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400%.
- Test Results: Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500%. After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400%.
- Conclusion: Passed.
- Freedom from Holes (Water Tight -1000 ml)-ASTM D6319-19 (Cross Reference D5151):
- Test Purpose: To determine the holes in the gloves.
- Acceptance Criteria: AQL 2.5.
- Test Results: Pass at AQL 2.5.
- Conclusion: Passed.
- Residual Powder on Medical Gloves (ASMT D6319-19 (ASTM D6124-11)):
- Test Purpose: To determine the residual powder in the gloves.
- Acceptance Criteria:
§ 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2021
BYD Auto Industry Company Limited % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong China
Re: K212840
Trade/Device Name: Nitrile Gloves (Model: NE01) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 30, 2021 Received: September 7, 2021
Dear Cassie Lee:
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,
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212840
Device Name Nitrile Gloves (Model: NE01)
Indications for Use (Describe)
A disposable device intended for medical purposes that is worn on the examiner's hand or fingers 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 summary of 510(K) is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: August 30, 2021
2. Submitter's Information
Sponsor Name: BYD Auto Industry Company Limited Address: No.3001, 3007, Hengping Road, Pingshan, Shenzhen, Guangdong Establishment Registration Number: Applying Post Code: 518119 Contact name: Jianling Liu Tel: +86 0755-89888888-67228 Tel: +86-136 3299 4277 E-mail: Liu.jianling@byd.com
Manufacture Factory:
Company: Hengchang(Dongying) Medical Technology Co.,Ltd. Address: No.26 Xinghe Road, Niuzhuang Town, Dongying Distict, Dongying City Contact name: Jianling Liu Tel: +86-136 3299 4277 E-mail: Liu.jianling@byd.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: regulatory@share-info.com
3. Subject Device Information
Type of 510(k): Traditional Common Name: Polymer Patient Examination Glove
4
| Sponsor: | BYD Auto Industry Company Limited |
|---|---|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |
Classification Name: Non-powdered patient examination glove Trade Name: Nitrile Gloves Model Name: NE01 Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Requlatory Class: Class I
4. Predicate Device Information
Sponsor: Nathan Trading Co., Ltd. Common Name: Polymer Patient Examination Glove Classification Name: Non-powdered patient examination glove Trade Name: LYDUS Nitrile Examination Gloves, Powder Free 510(k) Number: K203191 Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Regulatory Class: Class I
5. Device Description
The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is NBR BLUE 7214 (which composed of Phthalocyanine blue (CAS No.147-14-8) and Propylene glycol (CAS No.57-55-6). The examination glove is smooth surface with textured fingertips and a rolled rim atthe cuff edge.
The examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
6. Intended Use / Indications for Use
A disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
7. Technological Characteristic Comparison to predicate device and conclusion
| Elements of Comparison | Subject Device | Predicate Device | Result |
|---|---|---|---|
| ------------------------ | ---------------- | ------------------ | -------- |
5
| Sponsor: | BYD Auto Industry Company Limited |
|---|---|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |
| Elements of Comparison | Subject Device | Predicate Device | Result |
|---|---|---|---|
| Company | BYD Auto Industry | ||
| Company Limited | Nathan Trading Co., Ltd. | -- | |
| 510 (k) Number | K212840 | K203191 | -- |
| Trade Name | Nitrile Gloves | Nitrile Examination Gloves, | |
| Powder Free | -- | ||
| Product Code | LZA | LZA | Same |
| Classification Name | Non-powdered patient | ||
| examination glove | Non-powdered patient | ||
| examination glove | Same | ||
| Classification | Class I | Class I | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications For Use | A disposable device | ||
| intended for medical | |||
| purposes that is worn on | |||
| the examiner's hand or | |||
| fingers to prevent | |||
| contamination between | |||
| patient and examiner. | LYDUS Nitrile Examination | ||
| Gloves, Powder Free is a | |||
| disposable device intended for | |||
| medical purposes that is worn | |||
| on the examiner's hand or | |||
| fingers to prevent contamination | |||
| between patient and examiner. | Same | ||
| Material of Use | Nitrile compound | Nitrile compound | Same |
| Color | Blue | Blue | Same |
| Texture | Finger Textured | Finger Textured | Same |
| Size | |||
| (ASTM D6319-19) | Small, Medium, Large, | ||
| Extra Large | Small, Medium, Large, Extra | ||
| Large | Same | ||
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single usage | Single usage | Same |
| Dimensions | |||
| (ASTM D6319-19) | Length: | ||
| For S: $\geq$ 220mm | |||
| For M/L/XL: $\geq$ 230mm | |||
| Width: | |||
| For S: 80 $\pm$ 10mm | |||
| For M: 95 $\pm$ 10 mm | |||
| For L: 110 $\pm$ 10 mm | |||
| For XL: 120 $\pm$ 10 mm | Length Min: 230 min | ||
| (for medium size) | |||
| Width Min: 95 $\pm$ 10 mm | |||
| (for medium size) | Same | ||
| Note 1 | |||
| Physical Properties | Before Aging: | Before Aging: | Same |
6
| Sponsor: | BYD Auto Industry Company Limited |
|---|---|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |
| Elements of Comparison | Subject Device | Predicate Device | Result |
|---|---|---|---|
| (ASTM D6319-19) | Tensile Strength: ≥14Mpa | ||
| Ultimate Elongation: | |||
| ≥500% |
After Aging:
Tensile Strength: ≥14Mpa
Ultimate Elongation:
≥400% | Tensile Strength: Min 14 Mpa
Ultimate Elongation: Min 500%
After Aging:
Tensile Strength: Min 14Mpa
Ultimate Elongation: Min 400% | |
| Thickness
(ASTM D6319-19) | Palm: ≥0.05mm
Finger: ≥0.05mm | Palm min. 0.05 mm
Finger min. 0.05 mm | Same |
| Powder Free
(ASTM D6319-19) | ≤2 mg/glove | ≤2 mg/glove | Same |
| Freedom from Holes (Water
Tight -1000 ml)-ASTM D6319-
19 (Cross Reference D5151) | Passed | Passed | Same |
| Biocompatibility - Skin
Sensitization (ISO 10993-
10:2010) | Under the conditions of the
study not a sensitization | Under the conditions of the
study not a sensitizer | Same |
| Biocompatibility - Skin Irritation
(ISO 10993-10:2010) | Under the conditions of
study not an irritation | Under the conditions of study
not an irritant | Same |
| Biocompatibility - Acute
Systemic Toxicity (ISO 10993-
11: 2017) | Under the conditions of the
study no systemic toxicity | No systemic toxicity under the
experimental conditions
employed | Same |
Comparison in Detail(s):
Note 1:
Although the "Dimensions" of subject device is a little difference with predicate devices, but they all met the requirements of the standard ASTM D6319-19..
8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
Performance Testing Summary: 1)
| Test Method | Test Purpose | Acceptance | Test Results | Conclusion |
|---|---|---|---|---|
| ------------- | -------------- | ------------ | -------------- | ------------ |
7
| Sponsor: | BYD Auto Industry Company Limited |
|---|---|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |
| Criteria | ion | |||
|---|---|---|---|---|
| ASMT D6319-19 Standard | ||||
| Specification for Nitrile | ||||
| Examination Gloves for | ||||
| Medical Application - | ||||
| Physical Dimensions Test | To determine the | |||
| width, length, and | ||||
| thickness of the | ||||
| gloves | Width: | Passed | ||
| For M: 95 $\pm$ 10mm | For M: 93~96mm | |||
| For L: 110 $\pm$ 10mm | For L: 104-107mm | |||
| For XL: 120 $\pm$ 10mm | For XL: | |||
| 112~116mm | ||||
| Length: | ||||
| For M: ≥230mm | For M: 236~239mm | |||
| For L: ≥230mm | For L: 236~239mm | |||
| For XL: ≥230mm | For XL: | |||
| 255~258mm | ||||
| Thickness: | For M: | |||
| Finger: ≥0.05mm | ||||
| Palm: ≥0.05mm | Finger: | |||
| 0.06~0.09mm | ||||
| Palm: 0.06~0.08mm | ||||
| For L: | ||||
| Finger: | ||||
| 0.06~0.08mm | ||||
| Palm: 0.06~0.08mm | ||||
| For XL: | ||||
| Finger: | ||||
| 0.08~0.10mm | ||||
| Palm: 0.06~0.09mm | ||||
| ASMT D6319-19 Standard | ||||
| Specification for Nitrile | ||||
| Examination Gloves for | ||||
| Medical Application - | ||||
| Physical Dimensions Test | To determine the | |||
| tensile strength | ||||
| and ultimate | ||||
| elongation before | ||||
| and after | ||||
| acceleration | ||||
| aging | Before Aging: | |||
| Tensile Strength: | ||||
| ≥14Mpa | ||||
| Ultimate | ||||
| Elongation: ≥500% | ||||
| After Aging: | ||||
| Tensile Strength: | ||||
| ≥14Mpa | ||||
| Ultimate | Before Aging: | |||
| Tensile Strength: | ||||
| ≥14Mpa | ||||
| Ultimate Elongation: | ||||
| ≥500% | ||||
| After Aging: | ||||
| Tensile Strength: | ||||
| ≥14Mpa | ||||
| Ultimate Elongation: | Passed |
8
| Sponsor: | BYD Auto Industry Company Limited |
|---|---|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |
| Elongation: ≥400% | ≥400% | |||
|---|---|---|---|---|
| ASTM D6319-19 (ASTM | ||||
| D5151-11) Standard Test | ||||
| Method for Detection of | ||||
| Holes in Medical Gloves | To determine the | |||
| holes in the | ||||
| gloves | AQL 2.5 | Pass at AQL 2.5 | Passed | |
| ASMT D6319-19 (ASTM | ||||
| D6124-11) Standard Test | ||||
| Method for Residual | ||||
| Powder on Medical | ||||
| Gloves | To determine the | |||
| residual powder | ||||
| in the gloves |