(196 days)
The Disposable nitrile gloves are 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.
The Disposable nitrile gloves are powder free nitrile examination gloves. The Disposable nitrile gloves will be provided in blue. It can be available in four specifications: S,M,L and XL. And it is non-sterile.
This document is a 510(k) submission for disposable nitrile gloves. It is primarily concerned with establishing substantial equivalence to a predicate device, not with a clinical study of AI performance. Therefore, many of the requested elements regarding AI model acceptance criteria and study design are not applicable to this document.
However, I can extract information related to the device's performance acceptance criteria and how they were proven in a non-clinical setting.
Here's the breakdown based on the provided document:
Device: Disposable nitrile gloves (K223280)
Purpose of the document: To demonstrate substantial equivalence to a legally marketed predicate device (K212924) and obtain FDA clearance for marketing.
Acceptance Criteria and Reported Device Performance
The device performance is evaluated against established ASTM and ISO standards for examination gloves.
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Pass | ||
| - Length (mm) | >230 | >230 | Pass | |
| - Width (mm) | S: 85±5 | S: 85 | Pass | |
| M: 95±5 | M: 95 | Pass | ||
| L: 105±5 | L: 105 | Pass | ||
| XL: 115±5 | XL: 115 | Pass | ||
| - Thickness (mm) (Finger) | ≥0.05 | 0.09-0.15 | Pass | |
| - Thickness (mm) (Palm) | ≥0.05 | 0.06-0.07 | Pass | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Met the requirements | Pass |
| ASTM D6124 | Powder Content | < 2.0mg (Meet ASTM D6124) | <0.1mg | Pass |
| ASTM D412 | Physical properties | |||
| - Before Aging (Tensile Strength) | ≥14MPa | Implied Pass (No specific value given, but overall result is "Pass") | Pass | |
| - Before Aging (Ultimate Elongation) | ≥500% | Implied Pass | Pass | |
| - After Aging (Tensile Strength) | ≥14MPa | Implied Pass | Pass | |
| - After Aging (Ultimate Elongation) | ≥400% | Implied Pass | Pass | |
| ISO 10993-5 | Cytotoxicity | No cytotoxic | Fail | Fail |
| ISO 10993-11 | Acute Systemic Toxicity | Non-acute systemic toxicity | Met the requirements | Pass |
| ISO 10993-10 | Irritation | Non-irritating | Met the requirements | Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Met the requirements | Pass |
Note: The "Fail" for Cytotoxicity for the subject device is inconsistent with "Same" for Biocompatibility in Table 6A comparing to the predicate and with the overall conclusion of safety and effectiveness. This might be a typo in the table or an acceptable failure within certain thresholds not explicitly stated, or the "Fail" refers to a specific condition that is ultimately deemed not relevant for the overall biocompatibility assessment in comparison to the predicate. Given the "Same" in Table 6A and the overall conclusion, it suggests the cytotoxicity was deemed acceptable in context.
Study Proving the Device Meets Acceptance Criteria
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test, but standard test methods (ASTM, ISO) typically specify sampling plans. This is a non-clinical laboratory testing report, not a human clinical study.
- Data Provenance: The manufacturing entity is HOLIK ASIA GROUP CO.,LTD based in Anhui Province, China. The testing would presumably be conducted by or for the manufacturer. The data is from laboratory testing, not human subjects.
- Retrospective or Prospective: This is prospective testing, as the device was manufactured and then tested against the specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes non-clinical performance testing of a physical device against established industry standards. "Ground truth" in the context of expert review for medical imaging or AI is not relevant here. The "ground truth" is defined by the objective measurement criteria of the ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3. Testing against physical properties does not involve adjudication by multiple human experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical medical device (gloves), not an AI algorithm. No human reader or AI assistance is involved. The document explicitly states: "Performance Testing - Clinical: Not Applicable." and "Performance Testing - Animal: Not Applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (gloves), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these tests is defined by the quantitative and qualitative requirements of the specific ASTM and ISO standards (e.g., tensile strength minimums, AQL levels for holes, maximum powder content, and biological reactivity thresholds). These are objective, standardized measurements.
8. The sample size for the training set
- Not Applicable. There is no AI model or training set for this device.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI model or training set for this device.
Summary regarding the nature of the study:
The study described is a non-clinical performance testing study. Its goal is to demonstrate that the physical and biological properties of the disposable nitrile gloves meet recognized consensus standards (ASTM and ISO) and are substantially equivalent to a predicate device. This type of submission (510(k)) for a Class I device (like examination gloves) typically does not require human clinical trials or involve AI.
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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.
May 8, 2023
Holik Asia Group Co., Ltd % Libray Chang Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai, 201306 China
Re: K223280
Trade/Device Name: Disposable nitrile gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 12, 2023 Received: April 12, 2023
Dear Libray Chang:
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 Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K223280
Device Name Disposable nitrile gloves
Indications for Use (Describe)
The Disposable nitrile gloves are 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.
| 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
K223280
| Type of submission | Traditional |
|---|---|
| Date prepared | April 12, 2023 |
| Submission sponsor | |
| Manufacturer Name | HOLIK ASIA GROUP CO.,LTD |
| Address | NO.18 Nanyi Road, Xuanzhou Economic Development |
| Zone, Liqiao Town, Xuanzhou District, Xuancheng City | |
| Anhui Province, China | |
| Tel | 86-13585161180 |
| monica@holikasia.com | |
| Contact Person | Monica Zhou |
| Device identification | |
| Trade Name | Disposable nitrile gloves |
| Regulation Number | 21 CFR 880.6250 |
| Regulation Name | Non-Powdered Patient Examination Glove |
| Device Classification | Class I |
| Product Code | LZA |
| Panel | General Hospital |
| Application correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New |
| District, Shanghai, China | |
| Tel | 86-13020102321 |
| Libray@spicagloble.com |
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Contact Person
Libray Chang
Predicate device information
| Sponsor | Shanxi Nacosa Medical Technology Co.,Ltd |
|---|---|
| Trade/Device Name | Nitrile Examination Gloves |
| 510(K) number | K212924 |
| Regulation Number | 21 CFR 880.6250 |
Indications for use
The Disposable nitrile gloves are 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.
Device description
The Disposable nitrile gloves are powder free nitrile examination gloves. The Disposable nitrile gloves will be provided in blue. It can be available in four specifications: S,M,L and XL. And it is non-sterile.
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
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Technological Characteristic Comparison
Provided below is a comparison of the subject device with the predicate device.
Table 6A: General Comparison
| Item | Subject Device K223280 | Predicate Device (K212194) | Comparison |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 888.6250 | 21 CFR 888.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable nitrile gloves are intended to beworn on the hands of examiners to preventcontamination between patient and examiner. Thisis a single-use, powder-free, non-sterile device. | The nitrile examination glove is intended to beworn on the hands of examiners to preventcontamination between patient and examiner.This is a single-use, powder-free,non-steriledevice. | Same |
| Material | Nitrile | Nitrile | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Blue | Blue | Same |
| Labeling | Single-use indication, powder free, device color, | Single-use indication, powder free, device color, | Same |
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| Information | device name,glove size and quantity, Non-Sterile | device name, glove size and quantity, Non-Sterile | ||||
|---|---|---|---|---|---|---|
| Dimensions(mm) | Length(mm): >230;Width(mm):S: 85±5mmM: 95±5mmL: 105±5mmXL: 115±5mmMeet the requirements of ASTM D6319-19 | Length(mm): >230;Width(mm):S: Average 84mmM: Average 95mmL: Average 111mmXL: Average 115mmMeet the requirements of ASTM D6319-19 | Similar | |||
| Thickness(mm) | Finger: 0.09-0.15Palm: 0.06-0.07 | Finger: 0.12-0.15Palm: 0.08-0.10 | Similar | |||
| PhysicalProperties | Before Aging | Tensile Strength | ≥14MPa | Tensile Strength | 17-38 MPa | Similar |
| Ultimate Elongation | ≥500% | Ultimate Elongation | 501-565% | Similar | ||
| After Aging | Tensile Strength | ≥14MPa | Tensile Strength | 18-43MPa | Similar | |
| Ultimate Elongation | ≥400% | Ultimate Elongation | 500-564% | Similar | ||
| Freedom from Holes | Be free from holes when tested in accordance withASTMD5151 | Be free from holes when tested in accordance withASTMD5151 AQL=2.5 | Similar | |||
| Powder Content | <0.1mgMeet the requirements of ASTM D6124 <2.0mg/gloves | 0.1-0.3mgMeet the requirements of ASTM D6124 <2.0mg/gloves | Similar | |||
| Biocompatibility | ISO 10993-10;Under the conditions of the study, not an irritantor a sensitizer. | ISO 10993-10;Under the conditions of the study, not an irritantor a sensitizer. | Same | |||
| ISO 10993-11;Under the condition of acute systemic toxicity test,the test article did not show acute systemic | ISO 10993-11;Under the condition of acute systemic toxicitytest, the test article did not show acute systemic | Same |
510(K) Summary
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510(K) Summary
| toxicity in vivo.ISO 10993-5Under conditions of the study, device extract iscytotoxic. | toxicity in vivo.ISO 10993-5Under conditions of the study, device extract iscytotoxic. | Same | |
|---|---|---|---|
| -- | ---------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------- | ------ |
Analysis:
The physical dimensions, physical properties and powder content with that of the predicate, but they all meet the requirements of ASTM D6319.
Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The proposed device complies with the following standards:
- · ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization. ●
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity. ●
- 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. .
- ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves. .
Table 6B: Summary of Non-clinical performance testing
| Test method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length(mm): >230; | Length(mm): >230/Pass; |
| Width(mm): | Width(mm): |
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510(K) Summary
| S: 85±5mm | S: 85mm/Pass | ||||
|---|---|---|---|---|---|
| M: 95±5mm | M: 95mm/Pass | ||||
| L: 105±5mm | L: 105mm /Pass | ||||
| XL: 115±5mm | XL: 115mm/Pass | ||||
| Thickness (mm): | Thickness (mm): | ||||
| Finger: ≥0.05 | Finger: 0.09-0.15/Pass | ||||
| Palm: ≥0.05 | Palm: 0.06-0.07/Pass | ||||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Pass | ||
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | <0.1mg/Pass | ||
| ASTM D412 | Physical properties | Before Aging | Tensile Strength | ≥14MPa | Pass |
| Ultimate Elongation | ≥500% | ||||
| After Aging | Tensile Strength | ≥14MPa | |||
| Ultimate Elongation | ≥400% | ||||
| ISO 10993-5 | Cytotoxicity | No cytotoxic | Fail | ||
| ISO 10993-11 | Acute Systemic Toxicity | Non- acute systemic toxicity | Pass | ||
| ISO 10993-10 | Irritation | Non-irritating | Pass | ||
| ISO 10993-10 | Sensitization | Non-sensitizing | Pass |
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Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable nitrile gloves are as safe, as effective, and performs as well as or better than the legally marketed predicated device K212924.
§ 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.