(222 days)
Not Found
No
The summary describes a standard patient examination glove and does not mention any AI or ML capabilities. The performance studies are based on physical and chemical properties, not algorithmic performance.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
The device is described as a patient examination glove, intended to prevent contamination between patient and examiner. Its purpose is protective, not diagnostic.
No
The device description clearly indicates it is a physical glove made of latex, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The described device is a patient examination glove. Its function is to create a physical barrier between the examiner and the patient to prevent contamination. It does not analyze any biological specimens or provide diagnostic information.
- Intended Use: The intended use clearly states it's for preventing contamination during patient examination.
- Testing: The testing performed (physical properties, leak tests, biocompatibility, chemotherapy drug permeation) relates to the glove's barrier function and safety for use, not to the analysis of biological samples.
The information provided clearly indicates this is a Class I medical device used for barrier protection, not for in vitro diagnostic purposes.
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 were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drugs Permeation The following chemicals have been tested with these gloves.
Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes *Carmustine (BCNU) 3.3 mg/ml 22.6 Cisplatin Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min Dacarbazine Doxorubicin HCL 2.0 mg/ml >240 min Etoposide 20.0 mg/ml >240 min Fluorouracil 50.0 mg/ml >240 min Ifosfamide 50.0 mg/ml >240 min Mitoxantrone 2 mg/ml >240 min Paclitaxel 6.0 mg/ml >240 min *Thio Tepa 10.0 mg/ml >43.9 Vincristine Sulfate 1.0 mg/ml >240 min
- WARNING: Not recommended for use with Carmustine and Thlotepa. Please note that following drugs have extremely low permeation times: Carmustine (BCNU): 22.6 minutes and Thiotepa: 43.9 munites
Product codes
LZA, LZC
Device Description
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
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 performance test result:
- Dimension: Meets minimum length, thickness, and width requirements for various sizes (XS, S, M, L, XL) as per ASTM D6319-19. Result: Same as predicate, Pass.
- Physical Properties (Before Ageing): Meets minimum tensile strength (14 MPa) and ultimate elongation (500%) as per ASTM D6319-19. Result: Similar to predicate.
- Physical Properties (After Aging): Meets minimum tensile strength (14 MPa) and ultimate elongation (400%) as per ASTM D6319-19. Result: Similar to predicate.
- Water Leak Test: Meets AQL 1.5 before aging and AQL 2.5 after aging, for 1000 ml water leak, as per ASTM D6319-19 and ASTM D5151-19 (G-I, AQL 2.5). Result: Similar to predicate, Meet.
- Powder Free Residue: Meets maximum 2mg/glove, as per ASTM D6319-19 and ASTM D6124-06. Result: Similar to predicate, Meet.
- Biocompatibility Test:
- Primary Skin Irritation Test (ISO 10993-10): No Irritation. Conclusion: Under the conditions of this study the test material did not cause an irritant response. Result: Same as predicate.
- Skin Sensitization Test (ISO 10993-10): No Irritation. Conclusion: Under the conditions of this study, the test material did not produce a skin sensitization effect. Result: Same as predicate.
- In Vitro Cytotoxicity Test (ISO 10993-5:2009): Conclusion: Under condition of this study, test material exhibited moderate cytotoxicity reactivity at 6.0 cm²/mL extract concentrations and no cytotoxicity reactivity at the 3.0 cm²/mL extract concentrations of the test. Result: Different from predicate (no data available for predicate).
- Acute Systemic Toxicity (ISO 10993-11): Conclusion: Under condition of this study, the test material showed no adverse biological reaction after administration of the sample's extract on the rats during the period of the study. Result: Different from predicate (no data available for predicate).
- Chemotherapy Drug Permeation Claim (ASTM D6978-05): Tested against various chemotherapy drugs with specified breakthrough detection times. Notable results include Carmustine (BCNU) at 22.6 min and ThioTepa at 43.9 min, with most others showing >240 min. Result: Similar to predicate, but with specific breakthrough times differing slightly for Carmustine and ThioTepa.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 9, 2022
Careglove Global SDN. BHD. Siti Ahmad Official Correspondent Careglove Global SDN BHD Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3, Senewang Industrial Estate Seremban, Negeri Sembilan Darul Khusus 70450 Malaysia
Re: K211666
Trade/Device Name: Powder Free Nitrile Examination Gloves, Blue Chemotest Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: November 25, 2021 Received: December 6, 2021
Dear Siti Ahmad:
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.
For 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)
Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, CHEMOTEST
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 were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drugs Permeation The following chemicals have been tested with these gloves.
Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes *Carmustine (BCNU) 3.3 mg/ml 22.6 Cisplatin Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min Dacarbazine Doxorubicin HCL 2.0 mg/ml >240 min Etoposide 20.0 mg/ml >240 min Fluorouracil 50.0 mg/ml >240 min Ifosfamide 50.0 mg/ml >240 min Mitoxantrone 2 mg/ml >240 min Paclitaxel 6.0 mg/ml >240 min *Thio Tepa 10.0 mg/ml >43.9 Vincristine Sulfate 1.0 mg/ml >240 min
- WARNING: Not recommended for use with Carmustine and Thlotepa. Please note that following drugs have extremely low permeation times: Carmustine (BCNU): 22.6 minutes and Thiotepa: 43.9 munites
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(K) SUMMARY K211666
CAREGLOVE GLOBAL SDN BHD Applicant:
- Location Lot 17479, Lorong Senawang 2/3 Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Phone No. (60) 6 6782377 Fax No. (60) 6 6785377
Contact Person: Lim Kwee Shyan
Summary Preparation Date: 5th January, 2021
Device Information
Trade Name:POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, CHEMOTEST Common Name:POWDER FREE NITRILE EXAMINATION GLOVES Classification Name: Patient Examination Gloves Product Code: LZA, LZC Regulation: 21 CFR 880.6250
Predicate Device Identification
510(k) Number: K162858, Device Name: Careplus Powder Free Nitrile Examination Glove, Blue, Chemotest
Device Description
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
Intended Use of Device
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.
Comparison of technological characteristics between the predicate and subject devices.
The Powder Free Nitrile Examination Gloves – Blue, Chemotest, are summarized with the following technological characteristic compared to ASTM D6319 or equivalent standards.
| Characteristic | Standard | Specification | Subject Device
Powder Free Nitrile
Examination
Gloves, Blue,
Chemotest)
K211666 | Predicate Device
(Careplus Powder
Free Nitrile
Examination Glove,
Blue, Chemotest)
K162858 | Remarks |
|----------------|----------|---------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------|
| Product Code | - | - | LZA, LZC | LZA, LZC | Same |
| Intended Use | - | - | Intended for medical
purposes that is worn on
the examiner's hand to
prevent contamination | Intended for medical
purposes that is worn
on the examiner's hand
to prevent | Same |
5
| | | | between patient and
examiner | contamination between
patient and examiner | |
|------------------------|---|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Design | - | - | Powder Free, Non-
Sterile, Ambidextrous,
Beaded Cuff | Powder Free, Non-
Sterile, Ambidextrous,
Beaded Cuff | Same |
| Indications for
Use | - | - | A patient examination
glove is a disposable
device intended for
medical purposes that is
worn on the examiner's
hand to prevent
contamination between
patient and examiner | A patient examination
glove is a disposable
device intended for
medical purposes that
is worn on the
examiner's hand to
prevent contamination
between patient and
examiner | Same |
| Construction | - | - | Ambidextrous, Polymer
Coated or Chlorinated,
Powder Free Nitrile | Ambidextrous, Polymer
Coated or Chlorinated,
Powder Free Nitrile | Same |
| Color
Description | - | - | Blue | Blue | Similar |
| Material | - | - | Nitrile | Nitrile | Same |
| Single Use | - | - | Yes | Yes | Same |
| Packaging | - | - | Packed in Dispenser
Boxes | Packed in Dispenser
Boxes | Same |
| Chemo Drugs
Claim | - | - | Chemo Claim | Chemo Claim | Same |
Summary of non-clinical performance test result
| Characteristic | Standard | Specification | Subject Device
Powder Free Nitrile
Examination
Gloves, Blue,
Chemotest)
K211666 | Predicate Device
(Careplus Powder
Free Nitrile
Examination
Glove, Blue,
Chemotest)
K162858 | Remarks |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Dimension | ASTM
D6319-19 | | | | Same |
| Length (size: XSmall), mm
Length (size: Small), mm
Length (size: Medium), mm
Length (size: Large), mm
Length (size: XLarge), mm | | 220 min
220 min
230 min
230 min
230 min | Meet 220mm min
Meet 220mm min
Meet 230mm min
Meet 230mm min
Meet 230mm min | Meet 220mm min
Meet 220mm min
Meet 230mm min
Meet 230mm min
Meet 230mm min | |
| Thickness (palm), mm
Thickness (finger), mm | | 0.05 min
0.05 min | Meet 0.05mm min
Meet 0.05mm min | Meet 0.05mm min
Meet 0.05mm min | |
| Width (size: XSmall), mm
Width (size: Small), mm
Width (size: Medium), mm
Width (size: Large), mm
Width (size: XLarge), mm | | 70 ± 10
80 ± 10
95 ± 10
110 ± 10
120 ± 10 | Meet 70 ± 10 mm
Meet 80 ± 10 mm
Meet 95 ± 10 mm
Meet 110 ± 10 mm
Meet 120 ± 10 mm | Meet 70 ± 10 mm
Meet 80 ± 10 mm
Meet 95 ± 10 mm
Meet 110 ± 10 mm
Meet 120 ± 10 mm | |
| Physical Properties | ASTM
D6319-19 | | | | Similar |
| (Before Ageing)
i) Tensile Strength (MPa)
ii) Ultimate Elongation (%) | | Min. 14
Min. 500 | Meet 14MPa min.
Meet 500% min | Meet 14MPa min.
Meet 500% min | |
| | | | | | |
| (After Aging)
i) Tensile Strength (MPa)
ii) Ultimate Elongation (%) | | Min. 14
Min. 400 | Meets 14MPa min
Meet 400% min. | Meets 14MPa min
Meet 400% min. | |
| Water Leak Test,
1000 ml
Before Aging, AQL
After Aging, AQL | ASTM
D6319-19
ASTM
D5151-19 | G- I, AQL 2.5
(FDA GII, AQL
2.5) | Meet AQL 1.5
Meet AQL 2.5 | Meet AQL 1.5
Meet AQL 2.5 | Similar |
| Powder Free Residue
ASTM
D6319-19
Powder Free Residue,
ASTM
mg/glove
D6124-06 | | Max. 2mg/glove | Meet 2mg/glove max. | Meet 2mg/glove max | Similar |
| Biocompatibility Test
i) Primary Skin Irritation
Test | ISO 10993-
10 | No Irritation
Animal | i) Primary Skin
Irritation Test.
Conclusion: Under the
conditions of this study
the test material did
not cause an irritant
response | i)Primary Skin
Irritation Test.
Conclusion: Under
the conditions of this
study the test
material did not
cause an irritant
response. | Same |
| ii)Skin Sensitization
Test | ISO 10993-
10 | No Irritation
Animal | ii)Dermal Sensitization
Test.
Conclusion: Under the
conditions of this
study, the test material
did not produce a skin
sensitization effect | ii)Dermal
Sensitization
Test.
Conclusion: Under
the conditions of this
study, the test
material did not
produce a skin
sensitization effect. | Same |
| iii) In Vitro Cytotoxicity
Test | ISO 10993-
5:2009 | - | iii) In Vitro Cytotoxicity
Test.
Conclusion: Under
condition of this study,
test material exhibited
moderate cytotoxicity
reactivity at 6.0 cm²/mL
extract concentrations
and no cytotoxicity
reactivity at the 3.0
cm²/mL extract
concentrations of the
test. | iii) No data available | Different |
| Iv) Acute Systemic Toxicity | ISO 10993-
11 | - | iv) Acute Systemic
Toxicity.
Conclusion: Under
condition of this study,
the test material
showed no adverse
biological reaction after
administration of the
sample's extract on the
rats during the period
of the study. | No data available | Different |
| Chemotherapy Drug
Permeation Claim | ASTM
D6978-05 | - | Carmustine (BCNU)
(3.3 mg/ml) - 22.6,
Cisplatin (1.0 mg/ml) -
240 min
Cyclophosphamide
(Cytoxan) (20.0 mg/ml) | Carmustine (BCNU)
(3.3 mg/ml) — 10.2
min
Cisplatin (1.0 mg/ml)
-
240 min,
Cyclophosphamide | Similar |
6
7
| | - >240 min
Dacarbazine (10 mg/ml) - >240 min
Doxorubicin HCL (2.0 mg/ml) - >240 min
Etoposide (20 mg/ml) - >240 min
Flurouracil (50 mg/ml) - >240 min
Ifosfamide (50.0 mg/ml) - >240 min
Mitoxantrone (2 mg/ml) - >240 min
Paclitaxel (6.0 mg/ml) - >240 min
ThioTepa (10.0 mg/ml) - 43.9
Vincristine Sulfate (1.0 mg/ml) - >240 min | (Cytoxan) (20mg/ml) - >240 min
Dacarbazine (10.0 mg/ml) - >240 min
Doxorubicin HCL (2.0 mg/ml) - >240 min
Etoposide (20.0 mg/ml) - >240 min
Flurouracil (50.0 mg/ml) - >240 min
Ifosfamide (50 mg/ml) - >240 min,
Mitoxantrone (2.0 mg/ml) - >240 min
Paclitaxel (6.0 mg/ml) - >240 min
ThioTepa (10.0 mg/ml) - >40.5 min
Vincristine Sulfate (1.0 mg/ml) - >240 min |
| -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Following is a table showing the actual measured parameters of the gloves (e.g. length, thickness, width, physical properties, etc.) as compare to ASTM. All data meets the standard reference requirement.
| Test | Standard | Acceptance Criteria | Result | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Freedom From | |||||||||||||||||||||||||||
| Holes | ASTM D6319-19 | ||||||||||||||||||||||||||
| ASTM D5151-19 | Meet requirement inspection level G-I, AQL 2.5 | Pass | |||||||||||||||||||||||||
| Dimension | ASTM D6319-19 | Size XSmall Small Medium Large XLarge Length, min. | |||||||||||||||||||||||||
| mm 220 230 Thickness, min. mm 0.05 Width, ± 10 | |||||||||||||||||||||||||||
| mm 70 80 95 110 120 | Pass | ||||||||||||||||||||||||||
| Physical | |||||||||||||||||||||||||||
| Properties | ASTM D6319-19 | Before Aging After Accelerated Aging Tensile | |||||||||||||||||||||||||
| Strength Ultimate | |||||||||||||||||||||||||||
| Elongation Tensile | |||||||||||||||||||||||||||
| Strength Ultimate | |||||||||||||||||||||||||||
| Elongation 14 MPa min. 500 % min. 14 MPa min. 400 % min. | Pass | ||||||||||||||||||||||||||
| Residual | |||||||||||||||||||||||||||
| Powder Content | ASTM D6319-19 | ||||||||||||||||||||||||||
| ASTM D6124-06 | Not more than 2 mg per glove | Pass |
Summary of Clinical Testing
Not applicable
Conclusions:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K211666, the Powder Free Nitrile Examination Glove Blue Chemotest is a safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K162858.