(86 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a nitrile glove, with no mention of AI or ML technology.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It is a barrier device and does not claim to treat or diagnose any medical condition.
No
Explanation: This device, a nitrile patient examination glove, is used to prevent contamination during examinations, not to diagnose a medical condition.
No
The device is a physical glove made of nitrile rubber, not software. The description focuses on material properties and physical performance testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical properties and manufacturing of a glove. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims
- Use in a laboratory setting
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical tests for this powder free nitrile examination glove included:
- Physical Properties (ASTM D412): Evaluated tensile (tension) properties of glove. Results: Passed for tensile strength and ultimate elongation across sizes XS-XL, both before and after aging.
- Dimension (ASTM D3767): Measured length, width, and thickness of glove. Results: Passed for all sizes (X-Small, Small, Medium, Large, X-Large) against specified minimum length, width ranges, and thickness minimums.
- Watertight (ASTM D5151): Detected holes that leak water. Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10. Results: Passed. For each size (XS, S, M, L, XL), the number of leakers found was within the acceptance criteria.
- Residual Powder (ASTM D6124): Determined amount of residual powder. Sample size: 5 pcs. Results: Passed (below 2mg per glove) with values ranging from 0.26mg/glove to 0.38mg/glove across sizes.
- Biocompatibility (ISO 10993-10, ISO 10993-5, ISO 10993-11): Primary Skin Irritation, Dermal Sensitization, and Acute Systemic Toxicity were tested. Results: All passed.
No clinical testing was included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Physical Properties:
- Before aging: Tensile Strength 27.8 – 33.1 Mpa, Ultimate Elongation 530 -600%
- After aging: Tensile Strength 31.5 – 35.3 Mpa, Ultimate Elongation 470- 550%
- Thickness: Finger min 0.10mm, Palm min 0.06mm
- Powder Free: Below 2mg of residual powder
- Watertight: AQL 1.5
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 3, 2022
Safeskin Retailing (HK) Limited % Stephan Toupan President Dawa Medical LLC 7320 NW 12th Street Suite 103 Miami, Florida 33126
Re: K222715
Trade/Device Name: Black Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: September 5, 2022 Received: September 8, 2022
Dear Stephan Toupan:
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.
1
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 -S
Bifeng Oian, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222715
Device Name
BLACK NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE
Indications for Use (Describe)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K222715 As required by 21CFR§807.92(c)
| 1.0 | Submitter:
Name | : Alvin Ho |
|-----|--------------------------|-----------------------------------------------------------------------------------------------------------------|
| | Address | : Safeskin Retailing (HK) Limited
26th Floor, Beautiful Group Tower, 77 Connaught Road
Central, Hong Kong |
| | Phone No. | : +6012 826 5625 |
| | Date of Summary Prepared | : 11 November 2022 |
2.0 Identification of the subject device:
| Trade Name: | Black Nitrile Powder-Free Patient Examination Glove, Non-
Sterile |
|-----------------------|----------------------------------------------------------------------|
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification | 1 |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code | LZA |
3.0 Predicate Device:
K190942
Trade Name : Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co., Ltd
Description of The Subject Device: 4.0
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
5.0 Indication for use:
A Nitrile 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.
6.0 Comparison of the Technological Characteristics of the Device:
The Black Nitrile Powder-Free Patient Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1
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Table 1
| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERISTICS | STANDARDS | PREDICATE | ||
| BLACK | CURRENT | |||
| BLACK | COMPARISON | |||
| ANALYSIS | ||||
| 510(k) Number | - | K190942 | K222715 | |
| Manufacturer(s) | - | Ever Growth (Vietnam) Co., Ltd | Safeskin Retailing (HK) Limited | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Black | Black | Same |
| Sterility | - | Non-Sterile | Non-Sterile | Same |
| Handedness | - | Ambidextrous | Ambidextrous | Same |
| Physical Properties |
Before Aging
Tensile Strength:
Ultimate Elongation:
After Aging Tensile
Strength:
Ultimate Elongation: | ASTM D6319 | 14Mpa, min
500% min
14Mpa, min
400% min | 27.8 – 33.1 Mpa
530 -600%
31.5 – 35.3 Mpa
470- 550% | Different but
within the ASTM
standard
Different but
within the ASTM
standard |
| Thickness:
- Finger
- Palm
Powder Free | ASTM D6319
ASTM D6124 | 0.05mm min
0.05mm min