(66 days)
The Disposable Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided document is a 510(k) Premarket Notification for Disposable Nitrile Examination Gloves. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length(mm): S:≥220; M/L/XL:≥230; Width(mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: S: >220/Pass; M/L/XL: >230/Pass; Width: S: 82-88 /Pass; M: 95-98/ Pass; L: 106-111/ Pass; XL:111-115/ Pass; Finger Thickness: 0.13-0.15/Pass; Palm Thickness: 0.09-0.12/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL=2.5 | 0/125/Pass (This implies 0 holes found in 125 samples, meeting the AQL of 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 << 2.0mg/glove | S:0.13 mg/glove; M:0.13 mg/glove; L:0.16 mg/glove; XL:0.11 mg/glove (All below 2.0mg/glove) |
| ASTM D412 | Physical properties | Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500%; After Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥400% | Before Aging: Tensile Strength: 20-34/Pass (vs ≥14MPa); Ultimate Elongation: 521-570/Pass (vs ≥500%); After Aging: Tensile Strength: 15-25/Pass (vs ≥14MPa); Ultimate Elongation: 470-545/Pass (vs ≥400%) |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under the condition of the study, the device extract showed cytotoxic / fail. (Note: This is a failure, indicating it did not meet the non-cytotoxic criterion.) Correction: The sentence in the document says "Under conditions of the study, device extract is cytotoxic" for the predicate in the comparison table, and then "Under the condition of the study, the device extract showed cytotoxic / fail" in the results. This indicates that their device extract was indeed cytotoxic according to the test results and it failed this specific criterion as reported. From the context below, it seems the failure was acknowledged and the device was still cleared based on overall safety. (In 510k submissions, sometimes minor failures are accepted if compensated by other factors or if the risk is deemed acceptable for the intended use.) |
| ISO 10993-11 | Acute systemic toxicity | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
2. Sample size used for the test set and the data provenance
- Test Set Sample Sizes:
- ASTM D5151 (Watertightness): 125 samples (stated as "0/125/Pass")
- ASTM D6319 (Dimensions), ASTM D6124 (Powder Content), ASTM D412 (Physical Properties): Specific sample sizes for each glove size (S, M, L, XL) are not explicitly stated, but the results are presented for each size.
- Biocompatibility (ISO 10993-5, -10, -11): Not explicitly stated, but these typically involve a certain number of replicates and control groups for in vitro or in vivo tests.
- Data Provenance: The document implies that the testing was conducted by or for the manufacturer, Jiangxi Handspro Products Solutions CO., LTD. in China. The data is from non-clinical testing designed to evaluate the physical and biological characteristics of the device. It is prospective in the sense that these tests were conducted intentionally for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable for this type of device and study. The "ground truth" for the non-clinical testing of medical gloves (like dimensions, physical properties, or biocompatibility) is established by adherence to recognized international and national standards (e.g., ASTM, ISO). There are no human experts "establishing ground truth" in the way a radiologist would for medical imaging. The standards themselves define the test methods and acceptance criteria.
4. Adjudication method for the test set
This is not applicable for non-clinical performance testing. Adjudication methods like "2+1" are relevant for clinical studies or expert review processes where subjective interpretations might differ. For objective measurements against established standards, the results are determined by the test execution itself.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening devices, not for disposable examination gloves.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" is defined by established international and national consensus standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10, ISO 10993-11). These standards specify the methods for measurement and the acceptable ranges for physical properties and biological responses.
8. The sample size for the training set
Not applicable. This device is a physical medical product (disposable gloves), not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As stated above, this device does not utilize a training set.
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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
December 4, 2022
Jiangxi Handspro Products Solutions CO., LTD. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161, East Lujiazui Rd.,Pudong Shanghai. 200120 China
Re: K223004
Trade/Device Name: Disposable 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: September 29, 2022 Received: September 29, 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.
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
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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); 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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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,
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
Enclosure
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Indications for Use
510(k) Number (if known) K223004
Device Name Disposable Nitrile Examination Gloves
Indications for Use (Describe)
The Disposable Nitrile Examination Gloves are disposable devices intended for medical purposes that are 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K223004
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
| Name: | JIANGXI HANDSPRO PRODUCTS SOLUTIONS CO., LTD |
|---|---|
| Address: | Chuangye Avenue, Fenglin Industrial Zone of Dean CountyJiujiang City, Jiangxi, China. |
| Tel: | +86-18616636918 |
| Contact: | Jun Yin |
Designated Submission Correspondent
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
|---|---|
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong, Shanghai200120 ,China |
| Tel: | +86-21-50313932 |
| Contact: | Mr. Boyle Wang |
| Email: | Info@truthful.com.cn |
Date of Preparation: Sep.29th,2022
2.0 Device Information
| Trade name: | Disposable Nitrile Examination Gloves |
|---|---|
| Common name: | Patient Examination Gloves |
| Classification name: | Non-powdered patient examination glove |
| Model(s): | S, M, L, XL |
| Production code: | LZA |
| Regulation number: | 21CFR880.6250 |
| Classification: | Class I |
| Panel: | General Hospital |
3.0 Predicate Device Information
| Manufacturer: | GUANG DONG KINGFA SCI. & TECH.CO., LTD. |
|---|---|
| Device: | Nitrile examination gloves |
| 510(k) number: | K203593 |
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4.0 Indication for Use
The Disposable Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
5.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
6.0 Technological Characteristic Comparison Table
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device(K223004) | PredicateDevice(K203593) | comparison |
| Product Code | LZA | LZA | same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable NitrileExamination Gloves aredisposable devices intendedfor medical purposes that areworn on the examiner'shands to preventcontamination betweenpatient and examiner. | The nitrile examinationglove is intended to beworn on the hands ofexaminers to preventcontaminationbetween patient andexaminer. This is asingle-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 Information | Single-use indication, powderfree, device color, devicename, glove size andquantity, non-Sterile | Single-use indication,powder free, devicecolor, device name,glove size and quantity,non-Sterile | same |
Table1-General Comparison
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| Dimensions(mm) | Length: | Length: | same |
|---|---|---|---|
| S:≥220 | S:≥220 | ||
| M/L/XL:≥230 | M/L/XL:≥230 | ||
| Width: | Width: | ||
| S: 80±10 | S: 80±10 | ||
| M: 95±10 | M: 95±10 | ||
| L: 110±10 | L: 110±10 | ||
| XL: 120±10 | XL: 120±10 | ||
| Thickness(mm) | Finger:≥0.05 | Finger:≥0.05 |
| Palm: ≥0.05 | Palm: ≥0.05 | |||||
|---|---|---|---|---|---|---|
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min | Same |
| UltimateElongation | 500% min | UltimateElongation | 500% min | Same | ||
| AfterAging | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min | Same | |
| UltimateElongation | 400%min | UltimateElongation | 400%min | Same | ||
| Freedom fromHoles | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | Be free from holes whentested inaccordancewithASTMD5151 AQL=2.5 | same | |||
| Powder Content | Meet the requirements ofASTM D6124 | Meet therequirements ofASTM D6124 | Same | |||
| Biocompatibility | ISO 10993-10.Under the conditions of thestudy, not an irritant or asensitizer | ISO 10993-10.Under the conditions ofthe study, not an irritantor a sensitizer | Same | |||
| ISO 10993-11.Under the condition ofacute systemic toxicity test,the test article did not showacute systemictoxicity in vivo. | ISO 10993-11.Under the conditionof acute systemictoxicity test, the testarticle did not showacute systemictoxicity in vivo. | same | ||||
| ISO 10993-5Under conditions of thestudy, device extract iscytotoxic | ISO 10993-5Under conditions of thestudy, device extract iscytotoxic | same |
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7.0 Summary of Non-clinical Testing
Non-clinical 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:
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.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
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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.
| TestMethod | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTMD6319 | PhysicalDimensionsTest | Length(mm):S:≥220;M/L/XL:≥230;Width(mm):S: 80±10;M: 95±10;L: 110±10;XL: 120±10Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | Length: S: >220/Pass;M/L/XL: > 230/PassWidth:S: 82-88 /PassM: 95-98/ PassL: 106-111/ PassXL:111-115/ PassFinger: 0.13-0.15/PassPalm: 0.09-0.12/Pass |
| ASTMD5151 | WatertightnessTestforDetection ofHoles | Meet the requirements of ASTM D5151AQL 2.5 | 0/125/Pass |
| ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124 <2.0mg/glove | S:0.13 mg/glove;M:0.13 mg/glove;L:0.16 mg/glove;XL:0.11 mg/glove |
| ASTMD412 | Physicalproperties | Before AgingTensileStrength≥14MPaUltimateElongation≥500%After AgingTensileStrength≥14MPaUltimateElongation≥400% | 20-34/Pass;521-570/Pass;15-25/Pass;470-545/Pass; |
| ISO10993-5 | Cytotoxicity | Non- cytotoxic | Under the condition ofthe study, the deviceextract showedcytotoxic / fail. |
| ISO10993-11 | Acute systemictoxicity | Non- acute systemictoxicity | Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass |
| ISO10993-10 | Irritation | Non-irritating | Under the conditionsof the study, not anirritant/ Pass |
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer./ Pass |
Table 2 - Summary of non-clinical performance testing
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8.0 _Summary of Clinical Testing
Clinical testing is not needed for this device.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable Nitrile Examination Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicated device.
§ 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.