(83 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a nitrile examination glove, with no mention of AI or ML technologies.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not provide any therapeutic benefit or treatment.
No
Explanation: The device is a patient examination glove, which is used to prevent contamination between patient and examiner. It does not analyze or interpret biological signals or data to make a diagnosis.
No
The device is a physical glove made of nitrile rubber, not software. The description details physical properties and testing, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device for personal protection and infection control.
- Device Description: The description focuses on the physical properties and material of the glove, not on any diagnostic function.
- Lack of Diagnostic Function: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
- Performance Studies: The performance studies listed are related to the physical integrity, barrier properties, and biocompatibility of the glove, not to any diagnostic accuracy or performance.
The information provided clearly indicates this is a medical device intended for barrier protection, not for in vitro diagnostic testing.
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. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves 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
Hand or finger
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)
Summary of Non-Clinical Testing 7.0
- Physical Properties
- Test Method: ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension)
- Purpose: To evaluate the tensile (tension) properties of the glove.
- Acceptance Criteria:
- Before aging: Tensile strength Min 14.0 MPa, Ultimate elongation Min 500%
- After aging: Tensile strength Min 14.0 MPa, Ultimate elongation Min 400%
- Results: All sizes (XS, S, M, L, XL, XXL) passed for both tensile strength and ultimate elongation before and after aging.
- Dimension
- Test Method: ASTM D3767 Standard Practice for Rubber—Measurement of Dimensions
- Purpose: To measure the length, width and thickness of glove
- Acceptance Criteria:
- X-Small: Length Min 220 mm, Width 70 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm
- Small: Length Min 220 mm, Width 80 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm
- Medium: Length Min 230 mm, Width 95 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm
- Large: Length Min 230 mm, Width 110 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm
- X-Large: Length Min 230 mm, Width 120 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm
- XX-Large: Length Min 230 mm, Width 130 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm
- Results: All sizes (XS, S, M, L, XL, XXL) passed all dimension criteria. Specific results for each size are provided in the tables.
- Watertight
- Test Method: ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- Purpose: To detect holes that leak water and thereby compromise the usefulness of the glove.
- Acceptance Criteria: Sample size: 200 pcs, AQL: 2.5, Acceptance No. 10. (Batch size 35,001 to 150,000, code L equivalent to 200 pieces with accept 10 and reject 11).
- Results:
- Size XS: 1 piece found with leaks.
- Size S: 0 pieces found with leaks.
- Size M: 0 pieces found with leaks.
- Size L: 1 piece found with leaks.
- Size XL: 1 piece found with leaks.
- Size XXL: 3 pieces found with leaks.
All results fell within the acceptance criteria. Status: Pass.
- Residual Powder
- Test Method: ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- Purpose: To determine the amount of residual and non-powder solids found on gloves.
- Acceptance Criteria: Less than 2 mg per glove.
- Results: Sample size: 5 pcs. All sizes (XS, S, M, L, XL, XXL) had residual powder results well below 2 mg/glove. Status: Pass.
- Biocompatibility
- Primary Skin Irritation
- Standard: ISO 10993-10:2021 (E)
- Purpose: Evaluate the possibility of skin irritation after single topical applications of the test sample extracts on the skin of test subjects.
- Acceptance Criteria: Observation of skin reaction for erythema and oedema on test subject.
- Results: Under the conditions of this study, the test material induced negligible irritation in a rabbit skin single-exposure test. Status: Pass.
- Dermal Sensitization
- Standard: ISO 10993-10: 2010 (E)
- Purpose: To evaluate sensitization (maximization test) to evaluate possibility of skin sensitization after topical applications of the test sample extracts on the test subjects.
- Acceptance Criteria: Observation of skin sites for erythema and oedema on test and control test subjects as per Magnusson and Klingman Grading.
- Results: Under the conditions of this study, the frequency of positive challenge results in sample extract and Negative control animals are 0%, the Positive control is 100%, where the test material did not produce a skin sensitization effect in the guinea pigs. Status: Pass.
- Acute Systemic Toxicity
- Standard: ISO 10993-11:2017 (E)
- Purpose: Evaluate the acute systemic adverse reactions after being injected into test subjects.
- Acceptance Criteria: No toxicity indication or death in the animal subjected to study.
- Results: Under the conditions of this study, the test item did not induce any acute systemic toxicity reaction in mice. Status: Pass.
- Primary Skin Irritation
Summary of Clinical Testing:
No clinical studies are included in this submission.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
February 13, 2024
W.A. Rubbermate Co., Ltd. Prachai Kongwaree President 4 Ramkhamhaeng 19 (Chareonploy) Huamark Bangkok, 10240 Thailand
Re: K233740
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: November 15, 2023 Received: November 22, 2023
Dear Prachai Kongwaree:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Allan Guan-S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510k Summary (K233740)
(As Required by 21 CFR 807.92)
1.0 Submitter:
| Name | Prachai Kongwaree, President, W.A. Rubbermate
CO., LTD.
W.A. RUBBERMATE CO., LTD. |
|--------------------------|------------------------------------------------------------------------------------------------|
| Address | 4 Ramkhamhaeng 19 (Chareonploy)
Huamark,
Bangkok, Thailand 10240 |
| Phone No. | 66-2-3189442 |
| Date of Summary Prepared | 13 February 2024 |
2.0 ldentification of the subject device:
| Trade Name: | : Black Nitrile Powder Free Patient Examination Glove, Non
Sterile |
|-----------------------|-----------------------------------------------------------------------|
| Common Name: | : Patient Examination Gloves |
| Classification Name : | : Non-powdered patient examination glove |
| Device Classification | : I |
| 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
4.0 Description of The Subject Device:
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured from nitrile rubber. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves 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 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.
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 as shown in Table 1
5
| CHARACTERISTICS | STANDARDS | PREDICATE | DEVICE PERFORMANCE | CURRENT | COMPARISON ANALYSIS |
|---|---|---|---|---|---|
| 510(k) Number | - | K190942 | K233740 | Different | |
| Manufacturer(s) | - | Ever Growth (Vietnam) Co., Ltd | W.A. Rubbermate CO., LTD. | Same | |
| Material | ASTM D6319-19 | Nitrile | Nitrile | Same | |
| Color | - | Black | Black | Same | |
| Sterility | - | Non-Sterile | Non-Sterile | Same | |
| Handedness | - | Ambidextrous | Ambidextrous | Same | |
| Physical Properties | ASTM D6319-19 | ||||
| Before Aging | |||||
| Tensile Strength: | |||||
| Ultimate Elongation: | 14Mpa, min | ||||
| 500% min | 15.7 – 39.8 Mpa | ||||
| 550 - 620% | Different but within the ASTM standard | ||||
| After Aging Tensile | |||||
| Strength: | |||||
| Ultimate Elongation: | 14Mpa, min | ||||
| 400% min | 17.0 – 40.6 Mpa | ||||
| 460 - 600% | Different but within the ASTM standard | ||||
| Length | ASTM D6319-19 | 230 mm min | Min 240 | Different but within the ASTM standard | |
| Thickness: |
- Finger
- Palm | ASTM D6319-19 | 0.05mm min
0.05mm min | | Min 0.13mm for (XS, S, M, L, XL, XXL)
Min 0.09mm for (XS, S, M, L, XL, XXL) | Different but within the ASTM standard |
| Powder Free | ASTM D6124 |