(192 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a standard examination glove, with no mention of AI or ML.
No
The device is a glove intended to prevent contamination between patient and examiner, not to treat a disease or condition.
No.
Explanation: The device is a "patient examination glove," which is used to prevent contamination between patient and examiner. It does not perform any diagnostic function such as identifying a disease or condition.
No
The device is a physical examination glove made of nitrile rubber, which is a hardware component. The description focuses on the physical properties and performance of the glove itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination. This is a barrier device used for physical protection and hygiene.
- Device Description: The description focuses on the material (nitrile rubber), manufacturing process (surface treatment), and physical characteristics (ambidextrous, single use).
- Lack of IVD Characteristics: An IVD device is 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 interact with or analyze such specimens.
- Performance Studies: The performance studies listed are related to the physical integrity and biocompatibility of the glove, not diagnostic accuracy or analysis of biological samples.
The device described is a Class I medical device (specifically, a patient examination glove) used for infection control and barrier protection.
N/A
Intended Use / Indications for Use
A 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. These gloves are designed for single use only and should be disposed after use.
Product codes
LZA
Device Description
The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
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
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 tests were conducted.
Physical Properties: Evaluated tensile properties of the glove.
Results: Before aging: Tensile strength 30.9Mpa (Min 14.0 MPa), Ultimate elongation 583% (Min 500%). After aging: Tensile strength 34.2Mpa (Min 14.0 MPa), Ultimate elongation 538% (Min 400%). All passed.
Watertight: Detected holes that leak water.
Sample size: 315 pcs. Inspection level: G1. AQL: 1.5. Acceptance No. 10.
Results: 0 pieces found with leaks. Passed.
Dimension: Measured length, width, and thickness of the glove for various sizes (X-Small, Small, Medium, Large, X-Large).
Results: All dimensions met the acceptance criteria according to ASTM D3767.
Residual Powder: Determined the amount of residual powder.
Sample size: 5 pcs. Requirement:
§ 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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 24, 2022
Rimba Glove SDN BHD % Michael Woude U. S agent Emergo Global Representative LLC, 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746
Re: K212916
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: February 13, 2022 Received: February 22, 2022
Dear Michael Woude:
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 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,
For BiFeng Oian, Ph.D. Acting 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) K212916
Device Name BLACK NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE
Indications for Use (Describe)
A 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. These gloves are designed for single use only and should be disposed after use.
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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1.0 Sponsor:
2.0
| Company Name | : Rimba Glove Sdn Bhd |
|---|---|
| Company Address | : Plot 37, Medan Tasek, Tasek Industrial Area, 31400 Ipoh, |
| Perak, Malaysia. | |
| Submitter: | |
| Name | : Zahari Bin Darus |
| Address | : Rimba Glove Sdn Bhd |
| Plot 37, Medan Tasek, Tasek Industrial Area, 31400 Ipoh, Perak, | |
| Malaysia. |
Date of Summary Prepared: 20th Aug 2021 (Revised date: 23rd March 2022)
3.0 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:
Phone No.
Fax No.
K190942
Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co. Ltd.
: +605-5483688
: +605-5481688
4.0 Description of The Device:
The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
| Design | : Ambidextrous (i.e. fit either hand) |
|---|---|
| Colour | : Black. |
| Intended use | : Single Use and Non-Sterile |
| Finishing | : Finger Textured. |
| Performance | : See Section 7 – Summary of Non-Clinical Testing |
| Storage | : The product is kept away from direct sunlight and fluorescent |
| lighting and stored in an environment with temperature not | |
| exceeding 40 degree C. |
4
Indication for use:
A 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. These gloves are designed for single use only and should be disposed after use.
Information for "Powder Free" Claim:
The finished powder free gloves meet ASTM D6319 requirements and are tested in according to ASTM D6124 method for powder measurement (less than 2mg per glove).
Glove Size and dimension:
Measurement is done as per ASTM D6319. Length is measured from the tip of the middle finger to the outside edge of the cuff. Width is measured at a level between the base of the index finger and the base of the thumb.
| Size | Palm Width (mm) | Length (mm) |
|---|---|---|
| X-Small | 70±10 | Minimum 240 |
| Small | 80+10 | Minimum 240 |
| Medium | 95+10 | Minimum 240 |
| Large | 110±10 | Minimum 240 |
| X-Large | 120±10 | Minimum 240 |
5.0 Technological Characteristics Comparison of the Device:
Provided below is the technological comparison of the subject device vs the predicate device as shown in Table 1.
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Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON
ANALYSIS |
|----------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | | PREDICATE
BLACK | SUBJECT DEVICE
BLACK | |
| 510(k) Number | - | K190942 | K212916 | |
| Manufacturer(s) | - | Ever Growth Enterprise
Corporation | Rimba Glove Sdn Bhd | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Black | Black | Same |
| Class | - | Class 1 | Class 1 | Same |
| Product Code | - | LZA | LZA | Same |
| Regulation | - | 21 CFR 880.6250 | 21 CFR 880.6250 | 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 | 30.9Mpa
583%
34.2Mpa
538% | Different but within
the ASTM standard
Different but within
the ASTM standard |
| Physical Dimension:
Thickness:
- Finger
- Palm
- Glove Length
- Palm Width | ASTM D6319 | 0.05mm min
0.05mm min
230mm
X Small :70 $\pm$ 10mm
Small :80 $\pm$ 10mm
Medium :95 $\pm$ 10mm
Large :110 $\pm$ 10mm
X Large :120 $\pm$ 10mm | 0.10mm
0.07mm
240mm
X Small :70 $\pm$ 10mm
Small :80 $\pm$ 10mm
Medium :95 $\pm$ 10mm
Large :110 $\pm$ 10mm
X Large :120 $\pm$ 10mm | Different but within
the ASTM standard
Same |
| Powder Free | ASTM D6124 |