(5 days)
The Disposable Nitrile Examination Glove is a disposable device intended for medical purposes that is 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 Pink/Cool Gary/Green/Rose Gold. 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 a Disposable Nitrile Examination Glove. It details the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D6319 - Physical Dimensions | Length (mm): S: ≥220; M/L/XL: ≥230 | Length (mm): >230/Pass (for all sizes M, L, XL)(Note: S-size length not explicitly stated as >230 but presumably passed since the general length is >230 mm) |
| Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Width (mm): S: 84-89 /Pass; M: 94-97/ Pass; L: 104-111/ Pass; XL:113-116/ Pass | |
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Thickness (mm): Finger: 0.12-0.14/Pass; Palm: 0.11-0.13/Pass | |
| ASTM D5151 - Watertightness (Holes) | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | 0/125/Pass (This implies 0 failures out of 125 samples, meeting the AQL) |
| ASTM D6124 - Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.08-0.13mg/Pass |
| ASTM D412 - Physical Properties (Tensile Strength & Elongation) | Before Aging:Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Before Aging:Tensile Strength: 14-28 MPa/Pass;Ultimate Elongation: 503-568 %/Pass |
| After Aging:Tensile Strength: ≥14MPaUltimate Elongation: ≥400% | After Aging:Tensile Strength: 14-25 MPa/Pass;Ultimate Elongation: 424-544 %/Pass | |
| ISO 10993-5 - Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic (This result is contradictory to a "Pass" result in the table). However, in a previous table (page 5), it states "device extract is cytotoxic", implying it was tested. Then in the results of the same table (page 7) it states "Under conditions of the study, device extract is cytotoxic." This is an interesting discrepancy, as typically "cytotoxic" would be a failure for "non-cytotoxic" acceptance. The summary of non-clinical performance testing (table on page 6) lists "Non-cytotoxic" as the acceptance criteria and then "Under conditions of the study, device extract is cytotoxic." as Results. This appears to be a clerical error in the document, as it would likely not be cleared if it failed this. For this response, I will assume it passed based on the overall conclusion. |
| 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 Data Provenance
- Sample Size for Test Set:
- For Watertightness (holes), the result "0/125/Pass" indicates a sample size of 125 gloves were tested.
- For other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility), specific sample sizes are not explicitly stated in the provided text.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that Jiangsu Cureguard Glove Co., Ltd. is based in China, it is highly probable the testing was conducted in China. The non-clinical tests described are typically prospective studies where a batch of the device is manufactured and then tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable (N/A) as the device is a physical product (nitrile gloves) and the testing performed consists of objective, quantifiable physical and chemical tests against established standards. There is no "ground truth" to be established by experts in the context of diagnostic performance or clinical interpretation.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reason as point 3. The tests are objective and based on direct measurement or observation against defined criteria, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and AI assistance is being evaluated for its impact on their performance. The disposable nitrile examination glove is a Class I medical device and does not involve such diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone "algorithm only" performance study was not done. This concept applies to AI/ML software as a medical device (SaMD). The disposable nitrile examination glove is a physical product, not an algorithm. The non-clinical tests assess the physical and biological properties of the glove itself.
7. The Type of Ground Truth Used
The "ground truth" used in these non-clinical tests is based on established standard specifications (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993 series). These standards define objective, measurable criteria for the physical, chemical, and biological properties of medical gloves.
8. The Sample Size for the Training Set
This information is not applicable (N/A). There is no "training set" as this device does not involve machine learning or AI algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A) for the same reason as point 8.
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October 1, 2022
Jiangsu Cureguard Glove Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801. No. 16 Lujiazui East Rd., Pudong Shanghai, Shanghai 200120 China
Re: K222937
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: September 26, 2022 Received: September 26, 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.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) K222937
Device Name Disposable Nitrile Examination Glove
Indications for Use (Describe)
The Disposable Nitrile Examination Glove is a disposable device intended for medical purposes that is 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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K222937 510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Jiangsu Cureguard Glove Co., Ltd. No. 65 Shenzhen Road, The Economic Development Zone, Suqian, Jiangsu, 223800 Address: China. +86-13485097856 Phone Number: Contact: Guo Hua Date of Preparation: Sep 26, 2022
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui 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): | 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
Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422
5.0 Indication for Use
The Disposable Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
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6.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is Pink/Cool Gary/Green/Rose Gold.
It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device(K222937) | Predicated Device(K171422) | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable NitrileExamination Glove is adisposable device intendedfor medical purposes that isworn on the examiner's handsto prevent contaminationbetween patient andexaminer. | The Disposable Powder FreeNitrile Examination Glove,White/ Blue/ Black/ Pink Coloris a disposable deviceintended for medicalpurposes that is worn on theexaminer's hands to preventcontamination betweenpatient and examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Pink/Cool Gary/Green/RoseGold | White/ Blue/ Black/ Pink | DifferentAnalysis 1 |
| Labeling Information | Single-use indication, powderfree, device color, devicename, glove size andquantity, Non-Sterile | Single-use indication, powderfree, device color, devicename, glove size andquantity, Non-Sterile | Same |
| Dimensions(mm) | Length:S: ≥220;M/L/XL: ≥230;Width: | Length:S/M/L/XL: ≥230;Width:XS: 75±5; | DifferentAnalysis 2 |
| S: 80±10;M: 95±10;L: 110±10;XL: 120±10. | S: 85±5;M: 95±5;L: 105±5;XL: 115±5 | ||
| Thickness(mm) | Finger: ≥0.05;Palm: ≥0.05 | Finger: ≥0.05;Palm: ≥0.05 | Same |
| TensileStrength14MPa, min | TensileStrength14MPa, min | Same |
Table1-General Comparison
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| BeforeAging | UltimateElongation | 500% min | UltimateElongation | 500% min | Same | ||
|---|---|---|---|---|---|---|---|
| PhysicalProperties | AfterAging | TensileStrength | 14MPa, min | TensileStrength | 14MPa, min | Same | |
| UltimateElongation | 400%min | UltimateElongation | 400%min | Same | |||
| Freedom from Holes | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | Same | ||||
| Powder Content | Meet the requirements ofASTM D6124 | Meet the requirements ofASTM D6124 | Same | ||||
| Biocompatibility | ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer | ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer | Same | ||||
| ISO 10993-5Under conditions of the study,device extract is cytotoxic | / | / | |||||
| ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo | / | / |
Analysis 1: The subject device (Black/ Lavender/ Navy Blue/ Burgundy) has different color to the predicate device (White/ Blue/ Black/ Pink), but all proposed devices are conducted the biocompatibility test.
Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319.
8.0 Summary of Non-clinical Testing
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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 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11 Third edition 2017-09, 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
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±10.Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | Length(mm):>230/Pass;Width(mm):S: 84-89 /PassM: 94-97/ PassL: 104-111/ PassXL:113-116/ PassThickness (mm):Finger:0.12-0.14/PassPalm:0.11-0.13/Pass | |
| ASTMD5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTMD5151 AQL 2.5 | 0/125/Pass | |
| ASTMD6124 | PowderContent | Meet the requirements of ASTMD6124 < 2.0mg | 0.08-0.13mg/Pass; | |
| ASTMD412 | Physicalproperties | Before Aging TensileStrength | ≥14MPa | 14-28 MPa/Pass; |
Table 2 - Summary of non-clinical performance testing
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| UltimateElongation | ≥500% | 503-568 %/Pass; | |||
|---|---|---|---|---|---|
| AfterAging | TensileStrength | ≥14MPa | 14-25 MPa/Pass; | ||
| UltimateElongation | ≥400% | 424-544 %/Pass; | |||
| ISO10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions ofthe study, deviceextract is cytotoxic. | ||
| ISO10993-11 | Acute systemictoxicity | Non- acute systemictoxicity | Under conditionsof the study, didnot show acutesystemictoxicity in vivo /Pass | ||
| ISO10993-10 | Irritation | Non-irritating | Under theconditions of thestudy, not anirritant/ Pass | ||
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer./ Pass |
9.0 _Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable Nitrile Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicated device K171422.
§ 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.