(93 days)
Not Found
No
The device description and intended use clearly define the device as disposable examination gloves, which are a physical barrier and do not involve any computational or analytical functions. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and the performance studies are focused on material properties and physical performance, not algorithmic evaluation.
No
The device is a non-sterile examination glove intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is a "Disposable Medical Nitrile Examination Glove" used to prevent contamination, not to diagnose a medical condition.
No
The device is a physical medical device (examination gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the material, color, powder status, and sterility, all related to its function as a barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
- Regulatory Classification: The device is classified under 21 CFR 880.6250, which is for Patient Examination Gloves, a Class I medical device. IVDs have their own specific classifications and regulations.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile). The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical testing was performed according to ASTM D6319-19 for physical dimensions, physical requirements, detection of holes, and residual powder. Biocompatibility testing was performed according to ISO 10993-10 for skin irritation and skin sensitization, and ISO 10993-5 for in vitro cytotoxicity. All tests passed the specified acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 18, 2021
Sugian Linglian Medical Technology Co., Ltd % Johnson Liu Consultant CNMED Consultant 31 Archer St Upper MT Gravatt, OLD 4122 Australia
Re: K212600
Trade/Device Name: Disposable Medical 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 6, 2021 Received: August 17, 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.
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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 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.
Clarence W. Murray, III, PhD 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)
K212600
Device Name
Disposable Medical Nitrile Examination Gloves (Non Sterile)
Indications for Use (Describe)
Disposable Medical Nitrile Examination Gloves (Non Sterile) 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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510(K) Summary (K212600)
Disposal Medical Nitrile Examination Gloves (Non Sterile)
Preparation Date: Aug 6th, 2021
1. SUBMITTER
Company Name: SUQIAN LINGLIAN MEDICAL TECHNOLOGY CO.. LTD Company Address: No 1 Rd Wanpi Industrial Park, Xinshuguan Road, Shuyang County, Suqian Jiangsu, CN 223699 Contact Person: Johnson Liu Telephone Number: +614-0158-9995 Email: Johnson(@cnmed.com.au
2. NAME OF THE DEVICE
Trade Name / Proprietary Name: Disposable Medical Nitrile Examination Gloves (Non Sterile) Device Name: Disposable Medical Nitrile Gloves 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 DEVICE
Predicate Device: K203191 Applicant: Nathan Trading Co., Ltd Device Name: LYDUS NITRILE EXAMINATION GLOVES, POWDER FREE 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 Nitrile Examination Gloves (Non sterile). The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. 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 Nitrile Examination Gloves (Non Sterile) are 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
| DEVICE PERFORMANCE | REMARKS | ||
|---|---|---|---|
| CHARACTERISTICS | SUBJECT | PREDICATE | |
| 510(k) Number | Pending | K203191 | - |
| Disposable Medical Nitrile | LYDUS Nitrile Examination | ||
| Device Name | Examination Gloves (Non Sterile) | Gloves, Powder Free | - |
| Product Code | LZA | LZA | Same |
| Indications for Use | Disposable Medical Nitrile | ||
| Examination Gloves (Non Sterile) are | |||
| disposable devices intended for | |||
| medical purpose that are worn on the | |||
| examiner's hand to prevent | |||
| contamination between patient and | |||
| examiner. The device is for over the- | |||
| counter use. | LYDUS Nitrile Examination | ||
| Gloves, Powder Free is a | |||
| disposable device | |||
| intended for medical purposes | |||
| that is worn on the examiner's | |||
| hand or fingers to prevent | |||
| contamination between patient | |||
| and examiner. | Same | ||
| Materials of Use | |||
| (ASTM | |||
| D6910/D6910M-19) | Nitrile compound | Nitrile compound | Same |
| Color | Blue | Blue | Same |
| Texture | Finger Textured | Finger Textured | Same |
| Size | |||
| (ASTM D6319-19) | Small, Medium, Large, | Small, Medium, Large, | |
| Extra Large | Same | ||
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single use | Single use | Same |
| Dimensions | |||
| (ASTM D6319-19) | Length Min. 230 min Width Min | ||
| 95+/-10 mm (for medium size) | Length Min. 230 min Width Min | ||
| 95+/-10 mm (for medium size) | Same | ||
| Physical Properties | |||
| (ASTM D6319-19) | Before Aging | ||
| Tensile Strength | |||
| Min 14 Mpa Ultimate Elongation | |||
| Min 500% | |||
| After Aging | |||
| Tensile Strength | |||
| Min 14 Mpa Ultimate Elongation | |||
| Min 400% | Before Aging | ||
| Tensile Strength | |||
| Min 14 Mpa Ultimate | |||
| Elongation Min 500% | |||
| After Aging | |||
| Tensile Strength | |||
| Min 14 Mpa Ultimate | |||
| Elongation Min 400% | Same | ||
| Thickness | |||
| (ASTM D6319-19) | Palm min 0.05 mm | ||
| Finger min 0.05 mm | Palm min 0.05 mm | ||
| Finger min 0.05 mm | Same | ||
| Powder Free | |||
| (ASTM D6319-19) |