(114 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No.
The device, a disposable examination glove, is intended for barrier protection, not for treating or rehabilitating a medical condition or ailment.
No
The device, examination gloves, is intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device is a physical glove made of nitrile and vinyl, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
- Intended Use: The intended use of these gloves is "to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the physical characteristics and materials of the gloves, not on any diagnostic capabilities.
- Performance Studies: The performance studies described are related to the physical properties and biocompatibility of the gloves, not to the accuracy or reliability of a diagnostic test.
The device is clearly described as a "disposable device intended for medical purpose that is worn on the examiner's hand." This aligns with the definition of a medical device used for protection and hygiene, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
LZA
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.
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 based on ASTM D6319-19 for Physical Dimensions Test, Physical Requirements Test, and Detection of Holes. The devices passed all tests. Biocompatibility testing was performed based on ISO 10993-10 for skin irritation and sensitization, and ISO 10993-5 for in vitro cytotoxicity. The device was not found to be an irritant or sensitizer, and showed mild cytotoxicity with a cytotoxic level of 2.
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
§ 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.
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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
1
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 Examination | |||
| Gloves 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 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. | A patient examination glove is a disposable | |||
| device intended for medical purposes that is | ||||
| worn on the hand of healthcare and similar | ||||
| personnel to prevent contamination between | ||||
| healthcare 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 Aging | |||
| Tensile Strength | ||||
| Min 14 Mpa | ||||
| Ultimate Elongation Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| Min 14 Mpa | ||||
| Ultimate Elongation Min 400% | ||||
| (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% | ||||
| (ASTM D6319-05) | Same | |||
| Thickness | Palm min 0.05 mm | |||
| Finger min 0.05 mm | ||||
| (ASTM D6319-19) | Palm min 0.05 mm | |||
| Finger min 0.05 mm | ||||
| (ASTM D6319-05) | Same | |||
| Powder Free | IN VITRO | |||
| CYTOTOXICITY – ISO | ||||
| 10993-5: 2009(E) | Under the conditions of the cytotoxicity study, testing | |||
| results showed mild systemic toxicity and cytotoxic | ||||
| level 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 D6319-19 | |||
| Standard Specification | |||
| for Nitrile Examination | |||
| Gloves for Medical | |||
| Application - Physical | |||
| Dimensions Test | To determine the | ||
| width, length, and | |||
| thickness of the | |||
| gloves | 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 | ||
| ASMT D6319-19 | |||
| Standard Specification | |||
| for Nitrile Examination | |||
| Gloves for Medical | |||
| Application - Physical | |||
| Requirements Test | To determine the | ||
| tensile strength and | |||
| ultimate elongation | |||
| before and after | |||
| acceleration 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 Method | |||
| for Detection of Holes in | |||
| Medical Gloves | To determine the | ||
| holes in the gloves | AQL 2.5 | Passed | |
| ASMT D6319-19 | |||
| (ASTM D6124-11) | |||
| Standard Test Method | |||
| for Residual Powder on | |||
| Medical Gloves | To determine the | ||
| residual powder in | |||
| the gloves |