(410 days)
Not Found
No
The device description and performance metrics are focused on the physical properties and barrier function of examination gloves, with no mention of AI/ML capabilities or data processing.
No.
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: This device is a patient examination glove, used to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove made of nitrile, which is a hardware component. The summary focuses on physical properties and performance testing related to the glove's material and construction.
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 "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for physical protection and hygiene during examinations.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This glove does not perform any such diagnostic test.
- Device Description: The description focuses on the physical characteristics of the glove (material, color, size, ambidextrous).
- Lack of IVD-related information: There is no mention of analyzing samples, detecting analytes, or any other activity associated with in vitro diagnostics.
Therefore, the device described is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic.
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.
Product codes
LZA
Device Description
Powder Free Nitrile Examination Glove, Black and dual color White-Blue are Class 1 Patient Examination Gloves. The dual color White-Blue is made dual color by double dipping. They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large, Double Extra-Large and Triple Extra-Large. Gloves meet the ASTM D6319-19 specification below: Size (XS, S, M, L, XL, XXL, XXXL), Length, min. mm (220, 230), Thickness, min. mm (finger 0.05, palm 0.05), Width, +- 10 mm (70, 80, 95, 110, 120).
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 Testing: The performance test data from the non-clinical test met the specifications from ASTM testing methodology.
Clinical Testing: Clinical data is not needed for medical gloves or of most devices cleared by the 510(k) process.
Key Metrics
Freedom from pin-holes: 1.5 and below
Width, mm:
Black: 78- 80, 86- 88, 96- 98, 106- 108, 116- 118, 120- 125, 126- 129
White-Blue: 78- 80, 86- 88, 95- 98, 107- 108, 115- 117, 122- 123, 129- 132
Length, mm:
Black: min. 293, min. 285, min. 287, min. 281, min. 282, min. 292, min. 290
White-Blue: min. 297, min. 285, min. 285, min. 286, min. 301, min. 289, min. 300
Thickness Palm, mm:
Black: min. 0.13, min. 0.15, min. 0.15, min. 0.16, min. 0.15, min. 0.12, min. 0.13
White-Blue: min. 0.15, min. 0.16, min. 0.15, min. 0.15, min. 0.14, min. 0.16, min. 0.14
Thickness Finger, mm:
Black: min. 0.18, min. 0.21, min. 0.21, min. 0.18, min. 0.21, min. 0.16, min. 0.20
White-Blue: min. 0.19, min. 0.20, min. 0.19, min. 0.20, min. 0.20, min. 0.20, min. 0.19
Tensile Strength Before aging, Mpa:
Black: min. 25
White-Blue: min. 25
Tensile Strength After aging, Mpa:
Black: min. 29
White-Blue: min. 26
Ultimate Elongation Before aging,%:
Black: min. 605
White-Blue: min. 606
Ultimate Elongation After aging,%:
Black: min. 559
White-Blue: min. 576
Powder Free:
Black: Max. 1.02
White-Blue: Max. 0.90
Biocompatibility Test:
i) Primary Skin Irritation Test: Under the conditions of this study, the test material did not cause and irritant response.
ii) Dermal Sensitization Test: Under the conditions of this study, the test material did not produce a skin sensitization effect.
iii) Acute Systemic Toxicity: Under the conditions of this study, the test material both inner and outer surface did not reveal.
iv) In vitro Cytotoxicity Test:
Black: Under the conditions of this study, the test material is Cytotox(grade >2) at undiluted, 1:2, and Non-cyctotoxic, grade 2) at undiluted, 1:2, 1:4, 1:8 and Non-cyctotoxic, grade
§ 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.
August 20, 2021
Careplus (M) SDN BHD Bee Khoo Quality Manager Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban. 70450 Mv
Re: K201857
Trade/Device Name: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 8, 2021 Received: July 12, 2021
Dear Bee Khoo:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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, 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201857
Device Name
Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
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.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K201857
510(K) SUMMARY
- 1.0 Applicant: CAREPLUS (M) SDN BHD
Address: Lot 120 & 121 . Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Phone No. 60-6-6772781 Fax No. 60-6-6772780
Contact Person Lim Kwee Shyan
- 2.0 Date of Summary 18th June, 2021
- 3.0 Device Information Device Name
POWDER FREE NITRILE EXAMINATION GLOVE BLACK AND DUAL COLOR WHITE-BLUE
| Common Name | : Exam Gloves |
|---|---|
| Classification Name | : Patient Examination Gloves (21 CFR 880.6250, LZA) |
| Classification Panel | : Non-powdered patient examination glove |
| Class | : I |
4.0 Predicate Device
Predicate device: Powder Free Nitrile Examination Glove White, 510(k) number K142858 and Powder Free Nitrile Examination Glove Blue, 510(k) number K142862, product code LZA.
5.0 Device Description
Powder Free Nitrile Examination Glove, Black and dual color White-Blue are Class 1 Patient Examination Gloves. The dual color White-Blue is made dual color by double dipping. They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large, Double Extra-Large and Triple Extra-Large. Gloves meet the ASTM D6319-19 specification below:
| Size | XS | S | M | L | XL | XXL | XXXL |
|---|---|---|---|---|---|---|---|
| Length, min. mm | 220 | 230 | NA | ||||
| Thickness, min. mm | |||||||
| finger | 0.05 | NA | |||||
| palm | 0.05 | ||||||
| Width, ± 10 mm | 70 | 80 | 95 | 110 | 120 | NA |
6.0 Indications for Use Statement
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.
4
K201857
7.0 Technological Characteristics
Following is a table summarized the technological characteristics compared to Predicate Device and equivalent standards:
| Parameter | Standard
Reference | Standard
Specification | Subject Glove
(Powder Free
Nitrile Examination
Glove, Black)
K201857 | Subject Glove
(Powder Free
Nitrile Examination
Glove, Dual Color
White-Blue)
K201857 | Predicate Device
(Nitrile Blue,
K142862
Nitrile White,
K142858) | Characteristics |
|------------------------------------------------------------------------------------|--------------------------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Product Code
Regulation number | - | - | LZA
21 CFR 880.6250 | LZA
21 CFR 880.6250 | LZA
21 CFR 880.6250 | Same |
| Class | - | - | I | I | I | Same |
| Material | - | - | Nitrile | Nitrile | Nitrile | Same |
| Color | - | - | Black | White-Blue | Blue, White | Similar |
| White Pigment | - | - | Titanium Dioxide | Titanium Dioxide | Titanium Dioxide | Same |
| Size | ASTM
D6319-19 | - | XS,S,M,L,XL, XXL,
XXXL | XS,S,M,L,XL, XXL,
XXXL | XS,S,M,L,XL | Similar |
| Water Tight Test,
1000ml | ASTM
D6319-19
ASTM
D5151-06 | G-I, AQL 2.5 | Meets specification | Meets specification | Meets specification | Same |
| Physical Properties
i) Before Ageing
Tensile Strength
Ultimate Elongation | ASTM
D6319-19 | Min. 14 Mpa
Min. 500 % | Meets specification | Meets specification | Meets specification | Same |
| ii) After Ageing
ii)Tensile Strength
Ultimate Elongation | ASTM
D6319-19 | Min. 14 Mpa
Min. 500 | Meets specification | Meets specification | Meets specification | Same |
| Powder Content | ASTM
D6319-19
ASTM
D6124-06 | Max.
2 mg/glove | Meets specification | Meets specification | Meets specification | Same |
| Biocompatability
Test
i) Primary Skin
Irritation Test | ISO 10993-
10 | | Conclusion: Under
the conditions of this
study, the test
material did not
cause and irritant
response. | Conclusion: Under
the conditions of this
study, the test
material did not
cause and irritant
response. | Conclusion: Under
the conditions of this
study, the test
material did not
cause and irritant
response. | Same |
| ii) Dermal
Sensitization Test | ISO 10993-
10 | | Conclusion: Under
the conditions of this
study, the test
material did not
produce a skin
sensitization effect. | Conclusion: Under
the conditions of this
study, the test
material did not
produce a skin
sensitization effect. | Conclusion: Under
the conditions of this
study, the test
material did not
produce a skin
sensitization effect. | Same |
| iii) Acute Systemic
Toxicity | ISO 10993-
11 | | Conclusion: Under
the conditions of this
study, the test
material both inner
and outer surface
did not reveal | Conclusion: Under
the conditions of this
study, the test
material both inner
and outer surface
did not reveal | Conclusion: Under
the conditions of this
study, the test
material both inner
and outer surface
did not reveal | Same |
5
K201857
| iv) In vitro Cytotoxicity
Test | ISO 10993-5 | Conclusions: Under
the conditions of this
study, the test
material is
Cytotox(grade >2) at
undiluted, 1:2, and
Non-cyctotoxic,
grade ≤2 at dilutions
1:4, 1:8;1:16,1:32
and 1:64 | Conclusions: Under
the conditions of this
study, the test
material is
Cytotox(grade >2) at
undiluted, 1:2, 1:4,
1:8 and Non-
cyctotoxic, grade ≤2
at dilutions;1:16,1:32
and 1:64 | White Nitrile:
Conclusions: Under
the conditions of this
study, the test
material is
Cytotox(grade >2) at
undiluted, 1:2, 1:4
and Non-cyctotoxic,
grade ≤2 at
dilutions, 1:8 ,
1:16,1:32 and 1:64
Blue Nitrile:
Conclusions: Under
the conditions of this
study, the test
material is
Cytotox(grade >2) at
undiluted, 1:2, 1:4,
1:8, 1:16 and Non-
cyctotoxic, grade ≤2
at dilutions;1:32 and
1:64 | Similar |
|-----------------------------------|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Single Use | - | Single Use | Single Use | Single Use | Same |
| Labeling | - | Single Use | Single Use | Single Use | Same |
| Intended Use | - | A patient
examination gloves
is a disposal device
intended for medical
purposes that is
worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner. | A patient
examination gloves
is a disposal device
intended for medical
purposes that is
worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner. | A patient
examination gloves
is a disposal device
intended for medical
purposes that is
worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner. | Same |
6
| Parameter | Standard References | Standard Specification | Device Performance
Black | Device Performance
White-Blue | Predicate Device |
|------------------------------------|---------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------|
| Freedom from pin-holes | ASTM D6319-19 | AQL 2.5 | 1.5 and below | 1.5 and below | 1.5 and below |
| Width, mm | ASTM D6319-19 | XS - 70 ± 10
S - 80 ± 10
M - 95 ± 10
L - 110 ± 10
XL- 120 ± 10
XXL- NA
XXXL- NA | 78- 80
86- 88
96- 98
106- 108
116- 118
120- 125
126- 129 | 78- 80
86- 88
95- 98
107- 108
115- 117
122- 123
129- 132 | Meet Specification |
| Length, mm | ASTM D6319-19 | XS - 220 min
S - 220 min
M - 230 min
L - 230 min
XL- 230 min
XXL- NA
XXXL- NA | min. 293
min. 285
min. 287
min. 281
min. 282
min. 292
min. 290 | min. 297
min. 285
min. 285
min. 286
min. 301
min. 289
min. 300 | Meet Specification |
| Thickness Palm, mm | ASTM D6319-19 | XS – 0.05 min
S - 0.05 min
M - 0.05 min
L - 0.05 min
XL- 0.05 min
XXL- NA
XXXL- NA | min. 0.13
min. 0.15
min. 0.15
min. 0.16
min. 0.15
min. 0.12
min. 0.13 | min. 0.15
min. 0.16
min. 0.15
min. 0.15
min. 0.14
min. 0.16
min. 0.14 | Meet Specification |
| Thickness Finger, mm | ASTM D6319-19 | XS – 0.05 min
S - 0.05 min
M - 0.05 min
L - 0.05 min
XL- 0.05 min
XXL- NA
XXXL- NA | min. 0.18
min. 0.21
min. 0.21
min. 0.18
min. 0.21
min. 0.16
min. 0.20 | min. 0.19
min. 0.20
min. 0.19
min. 0.20
min. 0.20
min. 0.20
min. 0.19 | Meet Specification |
| Tensile Strength Before aging, Mpa | ASTM D6319-19 | 14 min | min. 25 | min. 25 | Meet Specification |
| Tensile Strength After aging, Mpa | ASTM D6319-19 | 14 min | min. 29 | min. 26 | Meet Specification |
| Ultimate Elongation Before aging,% | ASTM D6319-19 | 500 min | min. 605 | min. 606 | Meet Specification |
| Ultimate Elongation After aging,% | ASTM D6319-19 | 400 min | min. 559 | min. 576 | Meet Specification |
| Powder Free | ASTM D6319-19 | Max. 2 | Max. 1.02 | Max. 0.90 | Meet Specification |
Summary of Non-Clinical Testing 8.0
The performance test data from the non-clinical test met the specifications from ASTM testing methodology.
Summary of Clinical Testing 9.0
Clinical data is not needed for medical gloves or of most devices cleared by the 510(k) process.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.