(157 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML technologies.
No
The device, a patient examination glove, is intended for preventing contamination, not for treating or diagnosing a disease or condition.
No
The device is a medical glove, designed to prevent contamination. It does not perform any diagnostic function. Its performance studies focus on physical properties and biocompatibility, not on detecting or diagnosing medical conditions.
No
The device is a physical examination glove, which is a hardware medical device, not software. The description focuses on material properties and physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner." This describes a barrier device used externally.
- Device Description: The description focuses on the physical properties and barrier function of the glove, referencing standards like ASTM D6319-19.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside of the living body) for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This glove's function is purely a physical barrier.
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 hands or fingers to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's hands or fingers
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 provided table summarizes non-clinical performance data based on various ASTM and ISO standards for the subject device.
- ASTM D6319-19: Dimensions: Tested length and width. Length acceptance criteria: XS-Minimum 220mm, S-Minimum 220mm, M-Minimum 230mm, L-Minimum 230mm, XL-Minimum 230mm. Results: XS: 240mm, S: 246mm, M: 240mm, L: 250mm, XL: 251mm (PASS). Width acceptance criteria: XS-70 ± 10mm, S-80 ± 10mm, M-95 ± 10mm, L-110 ± 10mm, XL-120 ± 10mm. Results: XS: 73mm, S: 84 mm, M: 93 mm, L: 104 mm, XL: 111mm (PASS).
- ASTM D6319-19: Physical Properties: Measured tensile strength and elongation before and after aging. Tensile Strength acceptance criteria: Before Aging: 14.0 MPa, After Aging: 14.0 MPa. Results: Before Aging: Minimal Value: 19.10 MPa, After Accelerated Aging: Minimal Value: 19.0 MPa. Ultimate Elongation acceptance criteria: Before Aging: min. 500%, After Aging: min. 400%. Results: Before Aging Minimal Value: 520%, After Aging Minimal Value: 480% (PASS).
- ASTM D6319-19: Thickness: Measured palm and finger thickness. Palm acceptance criteria: Min. 0.05mm. Results: XS: 0.07mm, S: 0.07mm, M: 0.07mm, L: 0.07mm, XL: 0.07mm. Finger acceptance criteria: Min. 0.05mm. Results: XS: 0.11mm, S: 0.11mm, M: 0.11mm, L: 0.11mm, XL: 0.12mm (PASS).
- ASTM D6319-19: Freedom from Holes Testing: Purpose is to detect presence of holes. Acceptance criteria: Meet AQL 2.5 at G1. Results: Meet AQL 2.5 at G1 (PASS).
- ISO 10993-10: Primary Skin Irritation: Purpose is to determine irritation potential. Acceptance criteria: Not an irritant. Results: Under the condition of study, not an irritant (PASS).
- ISO 10993-10: Dermal Sensitization: Purpose is to determine sensitization potential. Acceptance criteria: Not a Sensitizer. Results: Under the condition of study, not a sensitizer (PASS).
- ISO 10993-11: Acute Systemic Toxicity: Purpose is to evaluate adverse systemic reaction potential. Acceptance criteria: Not induce systemic toxicity. Results: Did not induce systemic Toxicity (PASS).
- ASTM D6124-06: Residual Powder Analysis: Purpose is to check amount of powder residue. Acceptance criteria: Residual powder test (
§ 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.
July 8, 2022
KGM Gloves Sdn. Bhd. Ooi Seng RA Manager Lot 18893 & 18894, Jalan Perusahaan 9, Kawasan Perusahaan Kamunting. Perak 34600 Malaysia
Re: K220284
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 10, 2022 Received: May 16, 2022
Dear Ooi Seng:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
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
2
Indications for Use
510(k) Number (if known) K220284
Device Name Powder Free Nitrile Examination Gloves (Blue)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers 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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3
1.0 510 (K) SUMMARY 510(k) Number: K220284
2.0 Submitter:
KGM Gloves Sdn. Bhd. Lot 18893 & 18894, Jalan Perusahaan 9, Kawasan Perusahaan Kamunting, 34600 Kamunting, Perak, Malaysia. Tel: +605-891 3612 Fax: +605-891 6612
Establishment Registration Number: 3020763216
Contact Person:
Ooi Loon Seng (Mdm) i) (ii) Contact No: +6012-4612918 Email: loonsenq54@gmail.com
Melissa Oon Contact No: +6012-4730656 Email: melissaoon@gmail.com
Date of Preparation : January 15, 2022
3.0 Name of the Device
Trade Name: Powder Free Nitrile Examination Glove (Blue) Classification Name: Patient Examination Glove Device Classification: Class I Regulation Number: 21 CFR 880.6250 Product Code: LZA
4.0 Identification of The Legally Marketed Predicate Device
Predicate Device Name: Powder Free Blue Nitrile Examination Glove Predicate 510(K) Number: K210375 Manufacturer's Name: Duramitt Sdn. Bhd. Device Classification: Class I Regulation Number: 21 CFR 880.6250 Product Code: LZA
5.0 Description of Device
Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
6.0 The Intended Use of Device
The Powder Free Nitrile Examination Glove (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
4
7.0 Summary of the Technological Characteristic Comparison of the Device
Provided below is a comparison of the subject device and the predicate device
| Characteristics and
Parameters | Proposed Device -
Powder Free Nitrile
Examination Gloves | Predicate Device -
Powder Free Blue
Nitrile Examination
Gloves (K210375) | Comparison |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | LZA | LZA | Identical |
| Intended Use | A patient examination
glove is a disposable
device intended for
medical purposes that is
worn on the examiner's
hands or fingers to
prevent contamination
between patient and
examiner. | A patient examination
glove is a disposable
device intended for
medical purposes that is
worn on the hand or
finger to prevent
contamination between
patient and examiner. | Identical |
| Device Classification | Class I | Class I | Identical |
| Device material | Nitrile
(Acrylonitrile butadiene) | Nitrile
(Acrylonitrile butadiene) | Similar |
| Colour | Blue | Blue | Similar |
| Instruction for
Use on Labeling | Single Use only. | Single Use only. | Identical |
| Construction | Ambidextrous | Ambidextrous | Identical |
| Freedom from holes | Meet AQL 2.5 at G1 | Meet AQL 1.5 at G1 | Same |
| Length:
XS-Minimum 220mm
S-Minimum 220mm
M-Minimum 230mm
L-Minimum 230mm
XL-Minimum 230mm | Minimal Value for Length:
XS: 240mm
S: 246mm
M: 240mm
L : 250mm
XL: 251mm | Average
XS:-
S: 242mm
M: 242mm
L : 243mm
XL:- | Similar |
| Width:-
XS-70 ± 10mm
S-80 ± 10mm
M-95 ± 10mm
L-110 ± 10mm
XL-120 ± 10mm | Minimal Value for Width:
XS: 73mm
S: 84 mm
M: 93 mm
L: 104 mm
XL: 111mm | Average
XS:-
S: 84mm
M: 96mm
L : 107mm
XL:- | Similar |
| Palm Thickness
Minimum 0.05mm | Palm Minimal Value:
XS: 0.07mm
S: 0.07mm
M: 0.07mm | Average
XS:-
S: 0.06mm
M: 0.06mm | Similar |
| | L : 0.07mm | L : 0.06mm | |
| | XL: 0.07mm | XL:- | |
| Finger Thickness
Minimum 0.05mm | Finger Minimal Value:
XS: 0.11mm
S: 0.11mm
M: 0.11mm
L : 0.11mm
XL: 0.12mm | Average
XS:-
S: 0.08mm
M: 0.08mm
L : 0.08mm
XL:- | Similar |
| Tensile Strength
(Before age)
Minimum 14.0MPa | Minimum 19.1MPa | Average 19.04MPa | Similar |
| Tensile Strength
(After Age)
Minimum 14.0MPa | Minimum 19.0MPa | Minimum 14.0MPa | Different |
| Ultimate Elongation
(Before age)
Minimum 500% | Minimum 520% | Average 560% | Similar |
| Ultimate Elongation
(After age)
Minimum 400% | Minimum 480% | Average 510% | Similar |
| Residual powder test
(