(90 days)
No
The device is a disposable medical examination glove, and the description and performance testing focus on physical properties and biocompatibility, with no mention of AI or ML.
No.
The device, a disposable nitrile medical examination glove, is intended for preventing contamination, not for treating or curing a disease or condition.
No
Explanation: The document explicitly states the device is "intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner." This indicates its purpose is protective and hygienic, not to diagnose a condition. The performance studies also focus on physical properties and biocompatibility, not diagnostic accuracy.
No
The device is a physical examination glove, not a software-only medical device. The description focuses on material properties and physical performance testing.
Based on the provided information, 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 hands or finger to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to diagnose a condition based on in vitro examination of specimens.
- Device Description: The description confirms it's a "powder free nitrile examination glove." This is a physical barrier device.
- Performance Studies and Key Metrics: The performance studies focus on physical properties (tensile strength, elongation, freedom from holes), biocompatibility (irritation, sensitization, toxicity), and powder content. These are relevant to the physical integrity and safety of a glove, not the diagnostic accuracy of a test. The document explicitly states that performance metrics for examination gloves are based on physical properties and freedom from holes, "not diagnostic accuracy metrics like sensitivity or specificity."
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition outside of the body.
In summary, the device is a medical glove used as a physical barrier, which falls under a different regulatory classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The disposable nitrile medical examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The subject device is powder free nitrile examination gloves. The subject device is available in color blue and white, and it provides five specifications: XS,S,M,L and XL. The subject device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands 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)
Study Type: Non-Clinical Testing (Biocompatibility and Performance Bench Testing)
Key Results:
- Biocompatibility Testing:
- Irritation Test (ISO 10993-23:2021): Pass (not an irritant)
- Skin Sensitization Test (ISO 10993-10:2021): Pass (not a sensitizer)
- In Vitro Cytotoxicity (ISO 10993-5:2009): Cytotoxic
- Acute Systemic Toxicity (ISO 10993-11:2017): Pass (did not show acute systemic toxicity in vivo)
- Performance Testing (Bench) per ASTM D6319-10:
- Physical Dimensions: Length, Width, and Thickness all passed according to ASTM D6319-19 specifications.
- Freedom from Holes: Complied with ASTM D6319-19 and ASTM D5151-19 (G-1, AQL 2.5).
- Powder Content: Complied with ASTM D6319-19,
§ 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
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January 19, 2023
Yangzhou Saraguard Medical Supplies Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K223250
Trade/Device Name: Disposable Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 20, 2022 Received: December 20, 2022
Dear Boyle 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.
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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 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.
Bifeng Qian -S
Bifeng Qian, M.D., 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223250
Device Name Disposable Nitrile Examination Glove
Indications for Use (Describe)
The disposable nitrile medical examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands 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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510(k) Summary
K223250
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Yangzhou Saraguard Medical Supplies Co.,Ltd. Name: Standard Workshop No. 1, Phase I, Comprehensive Bonded Zone, No. 9, Address: Yangtze Jiangnan Road, Yangzhou City, Jiangsu Province, China Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: Oct.21,2022
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Nitrile Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS,S, M, L, XL
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Predicate Device#:
| Manufacturer: | Ever Global (Vietnam) Enterprise Corp |
|---|---|
| Device: | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color |
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510(k) number: K171422
Reference Device#:
Manufacturer: GUANG DONG KINGFA SCI. & TECH.CO., LTD. Device: Nitrile examination gloves 510(k) number: K203593
5.0 Indication for Use
The disposable nitrile medical examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is available in color blue and white, and it provides five specifications: XS,S,M,L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
Table1-General Comparison
5
| Item | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| Product Code | LZA | LZA | LZA | Same |
| 510(k) Reference | K223250 | K171422 | K203593 | |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | I | Same |
| Intended | ||||
| Use/Indication for Use | The disposable nitrile | |||
| medical | ||||
| examination | ||||
| glove is a non-sterile | ||||
| disposable | ||||
| device | ||||
| intended for medical | ||||
| purposes that is worn on | ||||
| the examiner's hands or | ||||
| finger to prevent | ||||
| contamination between | ||||
| patient and examiner. | The Nitrile powder free | |||
| patient examination Glove, | ||||
| is a non-sterile disposable | ||||
| device intended for | ||||
| medical purposes that is | ||||
| worn on the examiner's | ||||
| hands or finger to prevent | ||||
| contamination between | ||||
| patient and examiner. | The nitrile examination | |||
| glove is intended to be worn | ||||
| on the hands of examiners | ||||
| to prevent contamination | ||||
| between patient and | ||||
| examiner. This is a single- | ||||
| use, powder-free, non- | ||||
| sterile device. | Same | |||
| Powdered or Powered | ||||
| free | Powdered free | Powdered free | Powdered free | Same |
| Device material | ||||
| composition | Nitrile | Nitrile | Nitrile | Same |
| Gloves sizes | XS,S,M,L,XL | XS,S,M,L,XL | S,M,L,XL | Same |
| If gloves are single | ||||
| use | Yes | Yes | Yes | Same |
| Design Feature | Ambidextrous | Ambidextrous | Ambidextrous | Same |
| Sterile vs Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Color | Blue/White | White/ Blue/ Black/ Pink | Blue | Similar |
| Dimensions - Length | Complies with ASTM | |||
| D6319-19: | ||||
| XS/S: ≥220 mm; | ||||
| M/L/XL: ≥230 mm. | Complies with ASTM | |||
| D6319-19: ≥230 mm. | Complies with ASTM | |||
| D6319-19: | ||||
| S:≥220; | ||||
| M/L/XL: ≥230 | Similar | |||
| Dimensions - Width | Complies with ASTM | |||
| D6319-19: | ||||
| XS: 70±10mm; | ||||
| S:80±10mm; | ||||
| M:95±10mm; | ||||
| L: 110±10mm; | ||||
| XL: 120±10mm; | Complies with ASTM | |||
| D6319-19: | ||||
| XS: 75±5mm; | ||||
| S:85±5mm; | ||||
| M:95±5mm; | ||||
| L: 105±5mm; | ||||
| XL: 115±5mm; | Complies with ASTM | |||
| D6319-19: | ||||
| S: 80±10mm; | ||||
| M: 95±10mm; | ||||
| L: 110±10mm; | ||||
| XL: 120±10mm | Similar | |||
| Dimensions - | ||||
| Thickness | Complies with ASTM | |||
| D6319-19 | ||||
| Palm:≥0.05mm | ||||
| Finger: ≥0.05mm | Complies with ASTM | |||
| D6319-19 | ||||
| Palm:≥0.05mm | ||||
| Finger: ≥0.05mm | Complies with ASTM | |||
| D6319-19 | ||||
| Palm:≥0.05mm | ||||
| Finger: ≥0.05mm | Same | |||
| Physical Properties - | ||||
| Tensile Strength | Complies with ASTM | |||
| D6319-19: | ||||
| Before Aging: ≥14MPa | ||||
| After Aging: ≥500% | Complies with ASTM | |||
| D6319-19: | ||||
| Before Aging: ≥14MPa | ||||
| After Aging: ≥500% | Complies with ASTM | |||
| D6319-19: | ||||
| Before Aging: ≥14MPa | ||||
| After Aging: ≥500% | Same | |||
| Physical Properties - | ||||
| Elongation | Complies with ASTM | |||
| D6319-19: | ||||
| Before Aging: ≥14MPa | ||||
| After Aging: ≥400% | Complies with ASTM | |||
| D6319-19: | ||||
| Before Aging: ≥14MPa | ||||
| After Aging: ≥400% | Complies with ASTM | |||
| D6319-19: | ||||
| Before Aging: ≥14MPa | ||||
| After Aging: ≥400% | Same | |||
| Freedom from Holes | Complies with ASTM | |||
| D6319-19 | ||||
| and ASTM D5151-19 | Complies with ASTM | |||
| D6319-19 | ||||
| and ASTM D5151-19 | Complies with ASTM | |||
| D6319-19 | ||||
| and ASTM D5151-19 | Same | |||
| G-1, AQL 2.5 | G-1, AQL 2.5 | G-1, AQL 2.5 | ||
| Powder Content | Complies with ASTM D6319-19, 240/Pass; | |||
| Width: | ||||
| Blue color: | ||||
| XS: 74-76 /Pass | ||||
| S: 82-86 /Pass | ||||
| M: 95-97/ Pass | ||||
| L: 104-106/ Pass | ||||
| XL:115-117/ Pass | ||||
| White Color: | ||||
| XS: 73-76 /Pass | ||||
| S: 80-87 /Pass | ||||
| M: 100-103/ Pass | ||||
| L: 104-106/ Pass | ||||
| XL:114-117/ Pass | ||||
| Thickness (mm): | ||||
| Finger: ≥0.05 | ||||
| Palm: ≥0.05 | Blue color: | |||
| XS: | ||||
| Finger:0.10-0.12/Pass | ||||
| Palm: 0.06-0.10/Pass | ||||
| S: | ||||
| Finger: 0.09-0.12/Pass | ||||
| Palm:0.07-0.09/Pass | ||||
| M: | ||||
| Finger: 0.08 -0.12/Pass | ||||
| Palm: 0.07-0.09/Pass | ||||
| L: | ||||
| Finger: 0.09-0.12/Pass | ||||
| Palm: 0.06-0.09/Pass | ||||
| XL: | ||||
| Finger: 0.11-0.12/Pass | ||||
| Palm: 0.06-0.09/Pass | ||||
| White Color: | ||||
| XS: |
Table 2 Biocompatibility Testing
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- -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 -
10
Medical Application.
Table 3 Non-Clinical Testing
11
12
| | After
Aging | Tensile
Strength | $\geq$ 14MPa | Blue color:
20-30/Pass.
White Color:
16-35/Pass. |
|--|----------------|------------------------|--------------|--------------------------------------------------------------|
| | | Ultimate
Elongation | $\geq$ 400% | Blue color:
511-565/Pass
White Color:
436-521/Pass. |
9.0 Discussion of Clinical and Performance Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K171422.