(115 days)
Not Found
No
The device description and performance studies focus on the physical and biocompatibility properties of examination gloves, with no mention of AI or ML.
No.
This device is an examination glove intended to prevent contamination, not to treat or diagnose a disease or condition.
No
Explanation: The device is a glove for preventing contamination, not for diagnosing medical conditions.
No
The device is a physical glove made of nitrile, not software. The description details material, physical properties, and performance testing related to a physical product.
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.
- Device Description: The description focuses on the physical properties and materials of the glove, and its classification as a Class I medical device under 21 CFR 880.6250 (Patient Examination Glove). This regulation specifically covers gloves used for examination purposes, not for in vitro diagnostic procedures.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing. IVDs are designed to perform tests on samples taken from the human body.
The information provided describes a standard medical examination glove, which is a Class I medical device used for barrier protection. It does not fit the definition or typical characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Disposable Medical 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.
Product codes
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). 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
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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
Non-clinical testing was performed according to ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application for physical dimensions (width, length, thickness), physical requirements (tensile strength and ultimate elongation before and after acceleration aging), freedom from holes (ASTM D5151-11), and residual powder (ASTM D6124-11).
Biocompatibility testing was performed according to ISO 10993-10 for skin irritation and sensitization, ISO 10993-5 for in vitro cytotoxicity, and ISO 10993-11 for acute systemic toxicity.
All tests indicated the device passed the specified acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 5, 2021
Jiangsu Cherish Medical Technology Co., Ltd % Johnson Liu Consultant Cnmed Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia
Re: K211075
Trade/Device Name: Disposable Medical Nitrile Examination Gloves (Non-Sterile) Regulatory Class: 21 CFR 880.6250 Product Code: LZA Dated: July 20, 2021 Received: July 26, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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, 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)
Device Name
Disposable Medical Nitrile Examination Gloves (Non-Sterile)
Indications for Use (Describe)
Disposable Medical 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 the word "Cherish" in a blue, sans-serif font. The word is written in all lowercase letters except for the first letter, which is capitalized. There is a small "TM" symbol in the upper right corner of the word. The word is the main focus of the image and is centered.
510(K) Summary (K211075)
DISPOSABLE MEDICAL NITRILE EXAMINATION GLOVES, NON-STERILE
Preparation Date: August 5th, 2021
1. SUBMITTER
Company Name: JIANGSU CHERISH MEDICAL TECHNOLOGY CO., LTD Company Address: No. 55 Maqianan Chaoyang Road, Jiaoxi Centralized Industrial Zone 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: Cherish Nitrile Examination Gloves Device Name: Disposable Medical 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 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). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
5. Indications for Use
Disposable Medical 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
| DEVICE PERFORMANCE | |||
|---|---|---|---|
| CHARACTERISTICS | SUBJECT | PREDICATE | REMARKS |
| 510(k) Number | K211075 | K203191 | - |
| Device Name | Disposable Medical Nitrile | ||
| Examination Gloves | |||
| Powder Free, Non sterile | LYDUS Nitrile Examination | ||
| Gloves, Powder Free | - | ||
| Product Code | LZA | LZA | Same |
| Intended Use/Indications for | |||
| Use | Disposable Nitrile Examination | ||
| Gloves Non-sterile is 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, | ||
| Extra Large | Small, Medium, Large, | ||
| Extra Large | Same | ||
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single usage | Single usage | 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) |