(114 days)
Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Disposable Medical Synthetic Nitrile Examination Gloves. Non-sterile. The subject device is a patient examination glove made from nittile and vinyl compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) summary for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile). It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Reference) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASMT D6319-19) | Width: 80 mm (±10mm) (for small size) 95 mm (±10mm) (for medium size) 110 mm (±10mm) (for large size) Length: 220 mm (Minimum) (for small size) 230 mm (Minimum)(for medium, large size) Thickness: (for all sizes) Finger -0.05 mm (Minimum) Palm -0.05mm (Minimum) | Passed |
| Physical Requirements (Tensile Strength & Ultimate Elongation) (ASMT D6319-19) | Before Acceleration Aging: Tensile Strength (MPa): 14 (Minimum) Ultimate Elongation (%): 500 (Minimum) After Acceleration Aging: Tensile Strength (MPa): 14 (Minimum) Ultimate Elongation (%): 400(Minimum) | Passed |
| Freedom from Holes (Water Tight -1000 ml) (ASTM D6319-19 (ASTM D5151-11)) | AQL 2.5 | Passed |
| Residual Powder on Medical Gloves (ASMT D6319-19 (ASTM D6124-11)) | < 2.0 mg/glove | 0.6 mg/glove, Passed |
| Skin Irritation (ISO 10993-10) | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Skin Sensitization (ISO 10993-10) | Under the conditions of the study not a sensitizer. | Under the condition of the study not a sensitizer. |
| In Vitro Cytotoxicity (ISO 10993-5) | No more than grade 2 cytotoxicity at 100% extract concentration | Under the conditions of the cytotoxicity study, the extract of the test article showed mild cytotoxicity to L-929 cells and the cytotoxic level was 2. (This meets the acceptance criteria of "no more than grade 2 cytotoxicity"). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for physical dimensions, holes, or residual powder). However, the general statement mentions that the device "meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application," implying that the testing was conducted according to the sampling plans outlined in these standards.
The data provenance is not explicitly stated in terms of country of origin for the test data, nor whether it was retrospective or prospective. It is implied that these are prospective tests performed on the manufactured gloves as part of the submission process to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this document. The "ground truth" for this medical device (examination gloves) is established through adherence to recognized international standards (ASTM and ISO) for physical, chemical, and biological properties, not by expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
This information is not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, such as imaging AI applications. Examination gloves do not involve human diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical medical device (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective measurement against established international standards. Specifically:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-11: Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-11: Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10: Biological evaluation of medical devices — Part 10: Tests for skin irritation and skin sensitization
- ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 23, 2021
Changzhou Universal Medical Equipment Co. Ltd Johnson Liu Consultant CNMED Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia
Re: K211667
Trade/Device Name: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 16, 2021 Received: August 24, 2021
Dear Johnson Liu:
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); 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,
For Clarence W. Murray, III, 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)
Device Name
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
Indications for Use (Describe)
Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand 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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Image /page/3/Picture/1 description: The image shows a logo with a circular teal border. Inside the border are five white stars evenly spaced around the top half of the circle. In the center of the circle are two Chinese characters stacked vertically. Below the characters is the text "Lian Shou" in a sans-serif font, also in teal. In the upper right corner of the image is the registered trademark symbol.
510(K) Summary K211667
DISPOSABLE MEDICAL SYNTHETIC NITRILE EXAMINATION GLOVES, NON-STERILE
Preparation Date: Aug 16th, 2021
1. SUBMITTER
Company Name: Changzhou Universal Medical Equipment Co.,Ltd Company Address: No.6,Xinxi Road, Xinbei District Changzhou, CN 213000 Contact Person: Johnson Liu Telephone Number: +614-0158-9995 Email: Johnson@cnmed.com.au
2. NAME OF THE DEVICE
Trade Name / Proprietary Name: Disposable Synthetic Nitrile Examination Gloves (Non Sterile) Device Name: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZA
3. IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
Primary Predicate Device: K102593 Applicant: Zibo Yingbo Medical Products Co., Ltd Device Name: Synthetic Nitrile Patient Examination Gloves - Powder free, Blue Colour Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital
4. DEVICE DESCRIPTION
The subject device in this 510(k) Notification is Disposable Medical Synthetic Nitrile Examination Gloves. Non-sterile. The subject device is a patient examination glove made from nittile and vinyl compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
5. INDICATIONS FOR USE OF THE DEVICE
Disposable Medical Synthetic Nitrile Examination Gloves, Non-sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES
| CHARACTERISTICS | DEVICE PERFORMANCE | PRIMARY PREDICATE | Result | |
|---|---|---|---|---|
| SUBJECT | ||||
| 510(k) Number | K211667 | K102593 | - | |
| Device Name | Disposable Medical Synthetic Nitrile ExaminationGloves Powder Free, Non sterile | Synthetic Nitrile Patient Examination Gloves -Powder free, Blue Color | - | |
| Product Code | LZA | LZA | Same | |
| Indications for Use | Disposable Nitrile Examination Gloves Non-sterile(Non sterile) is disposable devices intended formedical purpose that are worn on the examiner's handto prevent contamination between patient andexaminer. The device is for over the-counter use. | A patient examination glove is a disposabledevice intended for medical purposes that isworn on the hand of healthcare and similarpersonnel to prevent contamination betweenhealthcare personal and the patient's body,fluids, waste or environment | Same | |
| Materials of Use | Nitrile and Vinyl compound | Synthetic Nitrile | Similar | |
| Color | Blue | Blue | Same | |
| Size(ASTM D6319-19) | Small, Medium, Large, | Small, Medium, Large,Extra Large | Same | |
| Sterilization | Non-sterile | Non-sterile | Same | |
| Usage | Single usage | Single usage | Same | |
| Dimensions | Width:80mm ±10mm (for small size)95mm ±10mm (for medium size)110 mm ±10mm (for large size)Length:220mm (Minimum) (for small size)230 mm (Minimum)(for medium, large size) | Comply with ASTM D6319-05 | Same | |
| Physical Properties | Before AgingTensile StrengthMin 14 MpaUltimate Elongation Min 500%After AgingTensile StrengthMin 14 MpaUltimate Elongation Min 400%(ASTM D6319-19) | Before AgingTensile StrengthMin 14 MpaUltimate Elongation Min 500%After AgingTensile StrengthMin 14 MpaUltimate Elongation Min 400%(ASTM D6319-05) | Same | |
| Thickness | Palm min 0.05 mmFinger min 0.05 mm(ASTM D6319-19) | Palm min 0.05 mmFinger min 0.05 mm(ASTM D6319-05) | Same | |
| Powder Free | <2 mg/glove (ASTM D6319-19) | <2 mg/glove (ASTM D6319-05) | Same | |
| Freedom from Holes (WaterTight -1000 ml) AQL2.5 | PassedASTM D6319-19 (Cross Reference D5151 | PassedASTM D6319-05 (Cross Reference D5151) | Same | |
| Biocompatibility -SKINSENSITIZATION - ISO10993-10: 2010 (E) | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Same | |
| Biocompatibility -SKINIRRITATION - ISO10993-10: 2010 (E) | Under the conditions of study not an irritant | Under the conditions of study not an irritant | Same | |
| Biocompatibility - IN VITROCYTOTOXICITY – ISO10993-5: 2009(E) | Under the conditions of the cytotoxicity study, testingresults showed mild systemic toxicity and cytotoxiclevel was 2. | No Testing Result available | Different | |
| Manufacturer(s) | Changzhou Universal Medical Equipment Co.,Ltd | Zibo Yingbo Medical Products Co., Ltd | -- |
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To sum up, the subject device and predicate devices are equivalent in terms of intended use, design, safety and performance.
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7. NON-CLINICAL TESTING SUMMARY
PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalDimensions Test | To determine thewidth, length, andthickness of thegloves | Width:80 mm (±10mm) (for small size)95 mm (±10mm) (for medium size)110 mm (±10mm) (for large size)Length:220 mm (Minimum)(for small size)230 mm (Minimum)(for medium, largesize)Thickness: (for all sizes)Finger -0.05 mm (Minimum)Palm -0.05mm (Minimum) | Passed |
| ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalRequirements Test | To determine thetensile strength andultimate elongationbefore and afteracceleration aging | Before Acceleration Aging:Tensile Strength (MPa): 14 (Minimum)Ultimate Elongation (%): 500 (Minimum)After Acceleration Aging:Tensile Strength (MPa): 14 (Minimum)Ultimate Elongation (%): 400(Minimum) | Passed |
| ASTM D6319-19(ASTM D5151-11)Standard Test Methodfor Detection of Holes inMedical Gloves | To determine theholes in the gloves | AQL 2.5 | Passed |
| ASMT D6319-19(ASTM D6124-11)Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powder inthe gloves | < 2.0 mg/glove | 0.6 mg/glove, Passed |
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BIO-COMPATIBILITY DATA
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ISO 10993-10 Biological evaluationof medical devices — Part 10: Testsfor skin irritation and skinsensitization | To determine the potential of thematerial under test to produce skinirritation in rabbits | Under the condition ofstudy not an irritant | Under thecondition of studynot an irritant |
| ISO 10993-10 Biological evaluationof medical devices — Part 10: Testsfor skin irritation and skinsensitization | To determine the skin sensitizationpotential of the material both interms of induction and elicitation inguinea pigs. | Under the conditions ofthe study not a sensitizer. | Under the conditionof the study not asensitizer. |
| ISO 10993-5 Biological evaluation ofmedical devices — Part 5: Tests for invitro cytotoxicity | To evaluate the in vitro cytotoxicpotential of the test item (both innerand outer surface) Extracts in L-929mouse fibroblasts cells using elutionmethod | No more than grade 2cytotoxicity at 100%extract concentration | Under the conditionsof the cytotoxicitystudy, the extract ofthe test articleshowed mildcytotoxicity to L-929cells and thecytotoxic level was2. |
8. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the Disposable Medical Synthetic Nitrile Examination Gloves Non sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate device K102593- Synthetic Nitrile Patient Examination Gloves – Powder free, Blue.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.