(180 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a medical glove, with no mention of AI or ML technology.
No
The device is a patient examination glove used to prevent contamination between patient and examiner, not to treat a disease or condition.
No
The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove made of synthetic rubber latex, which is a hardware component.
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 hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and material of the glove, consistent with a barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical properties, water tightness, chemical permeation, and biocompatibility, which are relevant for a protective glove, not an IVD.
- Key Metrics: The document explicitly states "Not Applicable (Performance metrics for diagnostic devices are not relevant for this device)".
Therefore, this device is a medical device, specifically a patient examination glove, but it does not meet the definition of an In Vitro Diagnostic device.
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 and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes) Azacitidine. 25mg/ml (25,000 ppm) >240mins Bleomycin Sulphate 15mg/ml (15,000 ppm)>240mins Carboplatin 10mg/ml (10,000 ppm) >240mins Carmustine (BCNU) 3.3mg/ml (3300 ppm) 22.5mins Cetuximab 2mg/ml (2000 ppm) >240mins Cisplatin 1mg/ml (1000 ppm) >240mins Cyclophosphamide (Cytoxan) 20mg/ml (20,000 ppm)>240mins Dacarbazine 10mg/ml (10,000 ppm)>240mins Docetaxel 10mg/ml (10,000 ppm) >240mins Doxorubicin HCl 2mg/ml (2,000 ppm) >240mins Ellence (Epirubicin) 2mg/ml (2,000 ppm) >240mins Etoposide 20mg/ml (20,000 ppm) >240mins Fluorouracil 50mg/ml (50.000 ppm) >240mins Gemcitabine 38mg/ml (38,000 ppm) >240mins Ifosfamide 50mg/ml (50,000 ppm) >240mins Irinotecan 20mg/ml (20,000 ppm) >240mins Methotrexate 25mg/ml (25,000ppm) >240mins Mitomycin C 0.5mg/ml (500 ppm) >240mins Mitoxantrone 2mg/ml (2,000 ppm) >240mins Oxaliplatin 2mg/ml (2,000ppm) >240mins Paclitaxel 6mg/ml (6,000 ppm) >240mins Rituximab 10mg/ml (10,000 ppm) >240mins Thio Tepa 10 mg/ml (10,000 ppm) 36.1 mins Vincristine Sulfate 1mg/ml 1,000 ppm) >240mins Vinorelbine 10mg/ml (10,000 ppm) >240mins Tested for Fentanyl Citrate is as follows: Fentanyl Citrate 100mcg/2ml >>240mins
Please note the following drugs have low permeation times Camustine (BCNU) 3.3mg/ml 22.5mins Thio Tepa 10mg/ml 36.1mins
Warning: Do not use these gloves with Camustine or Thio Tepa.
Product codes
LZA, LZC, QDO
Device Description
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-clinical tests were conducted to evaluate the performance of the device.
Test Method: Physical Properties
- Standard: ASTM D412-16 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension)
- Purpose: To evaluate the tensile (tension) properties of glove.
- Acceptance Criteria: Before aging: Tensile Strength Min 14 MPa, Ultimate Elongation Min 500%; After aging: Tensile Strength Min 14 MPa, Ultimate Elongation Min 400%
- Results: Before aging: Tensile Strength 14.4, Ultimate Elongation 506; After aging: Tensile Strength 16.3, Ultimate Elongation 402. All Pass.
Test Method: Dimension
- Standard: ASTM D3767-03(2020) Standard Practice for Rubber – Measurement of Dimensions
- Purpose: To measure the length, width, and thickness of glove
- Acceptance Criteria: Length Min 240mm; Width: XS 70 ± 10 mm, S 80 ± 10 mm, M 95± 10 mm, L 110 ± 10 mm, XL >110; Thickness: Finger – 0.05mm, Palm – 0.05mm
- Results: Length Min 240mm (Actual: Min 240); Width: Ave = 72 mm (XS), Ave = 83 mm (S), Ave = 95 mm (M), Ave = 104 mm (L), Ave = 115 mm (XL); Thickness: Finger – 0.08mm, Palm – 0.05mm. All Pass.
Test Method: Water Tight
- Standard: ASTM D 5151-19 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: 500, Inspection Level: GI, AQL: 1.5, Acceptance No: 14
- Results: This batch sampling is 500,001 and over. Hence according to single sampling plan GI, the sample to be drawn is under Code M equivalent to 500 pieces with accept 14 and reject 15. During the test, 12 pieces were found with leaks. Hence it falls within the acceptance criteria. Pass.
Test Method: Residual Powder
- Standard: ASTM D6124-06 (2017) Standard Test Method for Residual Powder on Medical Gloves
- Purpose: To determine the amount of residual powder and non-powder solids found on gloves
- Acceptance Criteria: Less than 2 mg per glove
- Results: Sample size: 5 pcs. Result: 1.5 mg/glove. Pass.
Test Method: Permeation by Chemotherapy Drugs
- Standard: ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs
- Purpose: To determine the minimum breakthrough Detection Time
- Acceptance Criteria: ≥240mins
- Results: ≥240mins Except for Carmustine and Thio Tepa (22.5mins for Carmustine, 36.1mins for Thio Tepa). Pass.
Test Method: Biocompatibility - Primary Skin Irritation
- Standard: ISO 10993-10:2010
- Purpose: To demonstrates the irritation potential of the gloves, i.e., for initiating or aggravating damage through its contact with the skin
- Acceptance Criteria: Not a primary skin irritant under the condition of this test.
- Results: Not a primary skin irritant. There was no erythema or oedema noted on test site after (1±0.1) , (24±2) , (48±2) and (72±2) hours. The primary Irritation Index (PII) was "0". Also, no mortality after 72 hours. The gloves considered negligible. Pass.
Test Method: Biocompatibility - Dermal Sensitization
- Standard: ISO 10993-10:2010
- Purpose: To demonstrate the potential of the device for eliciting a delayed hypersensitivity (Type IV) immunologic response through its contact with the skin.
- Acceptance Criteria: Not a contact sensitizer under the condition of this test.
- Results: Not a contact sensitizer. There was no positive allergic reaction observed during the challenge phase (at 0, 24 hours and 48 hours) in animals treated with the test material and negative control. Pass.
Test Method: Biocompatibility - Cytotoxicity - MEM Elution
- Standard: ISO 10993-5:2009
- Purpose: To assess cytotoxicity reactivity caused by this glove
- Acceptance Criteria: At which level of extract concentration, the glove exhibits no cytotoxicity reactivity under the condition of this test.
- Results: Exhibit severe cytotoxicity reactivity at 100%, 50%, and 25% extract concentration. No cytotoxicity reactivity at 12.5%, 6.25% and 3.125% extract concentrations. Not Pass.
Test Method: Biocompatibility - Acute Systemic Toxicity
- Standard: ISO 10993-11:2017 (E)
- Purpose: To demonstrate adverse effect occurring at any time within 72hours after single exposure
- Acceptance Criteria: no adverse biological reaction under the condition of this test.
- Results: no adverse biological reaction under the condition of this test. Pass.
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.
April 17, 2022
Meditech Gloves SDN BHD Wan Hassan Assistant Manager- OA/RA PT 3345, Jalan Permata 1/3, Arab Malaysian Industrial Park Nilai, Negeri Sembilan 71800 Malaysia
Re: K213408
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: March 12, 2022 Received: March 22, 2022
Dear Wan Hassan:
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 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,
Bifeng Oian, M.D., 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
2
Indications for Use
510(k) Number (if known) K213408
Device Name
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) tested for use with Chemotherapy Drugs and Fentanyl Citrate
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 and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes) Azacitidine. 25mg/ml (25,000 ppm) >240mins Bleomycin Sulphate 15mg/ml (15,000 ppm)>240mins Carboplatin 10mg/ml (10,000 ppm) >240mins Carmustine (BCNU) 3.3mg/ml (3300 ppm) 22.5mins Cetuximab 2mg/ml (2000 ppm) >240mins Cisplatin 1mg/ml (1000 ppm) >240mins Cyclophosphamide (Cytoxan) 20mg/ml (20,000 ppm)>240mins Dacarbazine 10mg/ml (10,000 ppm)>240mins Docetaxel 10mg/ml (10,000 ppm) >240mins Doxorubicin HCl 2mg/ml (2,000 ppm) >240mins Ellence (Epirubicin) 2mg/ml (2,000 ppm) >240mins Etoposide 20mg/ml (20,000 ppm) >240mins Fluorouracil 50mg/ml (50.000 ppm) >240mins Gemcitabine 38mg/ml (38,000 ppm) >240mins Ifosfamide 50mg/ml (50,000 ppm) >240mins Irinotecan 20mg/ml (20,000 ppm) >240mins Methotrexate 25mg/ml (25,000ppm) >240mins Mitomycin C 0.5mg/ml (500 ppm) >240mins Mitoxantrone 2mg/ml (2,000 ppm) >240mins Oxaliplatin 2mg/ml (2,000ppm) >240mins Paclitaxel 6mg/ml (6,000 ppm) >240mins Rituximab 10mg/ml (10,000 ppm) >240mins Thio Tepa 10 mg/ml (10,000 ppm) 36.1 mins Vincristine Sulfate 1mg/ml 1,000 ppm) >240mins Vinorelbine 10mg/ml (10,000 ppm) >240mins Tested for Fentanyl Citrate is as follows: Fentanyl Citrate 100mcg/2ml >>240mins
Please note the following drugs have low permeation times Camustine (BCNU) 3.3mg/ml 22.5mins Thio Tepa 10mg/ml 36.1mins
Warning: Do not use these gloves with Camustine or Thio Tepa.
3
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
1.0 Submitter:
| Name: | Dr Effendi Tenang |
|---|---|
| Address: | Meditech Gloves Sdn Bhd |
| PT3345, Jalan Permata 1/3, Arab Malaysian Industrial Park, | |
| 71800 Nilai, Negeri Sembilan, MALAYSIA | |
| Phone No.: | +60 6 799 7742 |
| Fax No.: | +60 6 799 7749 |
Date of Summary Prepared: April 15, 2022
2.0 Name of the device:
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Common Name: Examination Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA, LZC, QDO)
3.0 Identification of The Legally Marketed Devices that equivalency is claimed:
Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) K192954 : Class I Regulatory : LZA, LZC, QDO Product Code :
4.0 Description of The Device:
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber Inner surface of gloves undergoes surface treatment process to produce a latex. smooth surface that assists the user in donning the gloves with ease 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.
5.0 Intended Use of the 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.
5
Г
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
T
| Chemotherapy Drug and Concentration | Minimum
Breakthrough
Detection Time
(Minutes) |
|-------------------------------------------------|--------------------------------------------------------|
| Azacitidine, 25mg/ml (25,000 ppm) | >240mins |
| Bleomycin Sulphate 15mg/ml (15,000 ppm) | >240mins |
| Carboplatin 10mg/ml (10,000 ppm) | >240mins |
| Carmustine (BCNU) 3.3mg/ml (3300 ppm) | 22.5mins |
| Cetuximab 2mg/ml (2000 ppm) | >240mins |
| Cisplatin 1mg/ml (1000 ppm) | >240mins |
| Cyclophosphamide (Cytoxan) 20mg/ml (20,000 ppm) | >240mins |
| Dacarbazine 10mg/ml (10,000 ppm) | >240mins |
| Docetaxel 10mg/ml (10,000 ppm) | >240mins |
| Doxorubicin HCl 2mg/ml (2,000 ppm) | >240mins |
| Ellence (Epirubicin) 2mg/ml (2,000 ppm) | >240mins |
| Etoposide 20mg/ml (20,000 ppm) | >240mins |
| Fluorouracil 50mg/ml (50,000 ppm) | >240mins |
| Gemcitabine 38mg/ml (38,000 ppm) | >240mins |
| Ifosfamide 50mg/ml (50,000 ppm) | >240mins |
| Irinotecan 20mg/ml (20,000 ppm) | >240mins |
| Methotrexate 25mg/ml (25,000ppm) | >240mins |
| Mitomycin C 0.5mg/ml (500 ppm) | >240mins |
| Mitoxantrone 2mg/ml (2,000 ppm) | >240mins |
| Oxaliplatin 2mg/ml (2,000ppm) | >240mins |
| Paclitaxel 6mg/ml (6,000 ppm) | >240mins |
| Rituximab 10mg/ml (10,000 ppm) | >240mins |
| Thio Tepa 10 mg/ml (10,000 ppm) | 36.1 mins |
| Vincristine Sulfate 1mg/ml 1,000 ppm) | >240mins |
| Vinorelbine 10mg/ml (10,000 ppm) | >240mins |
6
Tested for Fentanyl Citrate is as follows:
Fentanyl Citrate 100mcg/2ml
240mins
Please note the following drugs have low permeation times Camustine (BCNU) 3.3mg/ml 22.5mins Thio Tepa 10mg/ml 36.1mins
Warning: Do not use these gloves with Camustine or Thio Tepa.
7
6.0 Comparison of the Technological Characteristics with the Predicate Device:
The Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards of the subject gloves to the predicate device
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | COMPARISON ANALYSIS | |
|---|---|---|---|---|
| PREDICATE | ||||
| BLUE | CURRRENT | |||
| BLUE | ||||
| 510(k) Number | - | K192954 | K213408 | |
| Manufacturer(s) | - | Comfort Rubber Gloves | ||
| Industries Sdn. Bhd. | Meditech Gloves Sdn Bhd | |||
| Material | ASTM D6319-19 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger textured | Finger textured | Same |
| Physical Properties | ASTM D6319-19 | Meets | Meets | Same |
| Thickness - Finger |
- Palm | ASTM D6319-19 | Min 0.05mm
Min 0.05mm | 0.07- 0.10mm
0.06- 0.09mm | Similar |
| Width | ASTM D6319-19 | XS Not Provided
S Not Provided
M Not Provided
L Not Provided
XL Not Provided | XS 70-75mm
S 80-86mm
M 93-97mm
L 102-106mm
XL 114-116mm | Different |
| | XS 70±10mm
S 80±10mm
M 95±10mm
L 110±10mm
XL >110mm | | | |
| Length | ASTM D6319-19 | Min 240mm | Min 240mm | Same |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | ≤ 2 mg/glove | Same |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON
ANALYSIS |
| | | PREDICATE
BLUE | CURRRENT
BLUE | |
| Biocompatibility | Primary Skin Irritation -
ISO 10993-10:2010 | Passes
Under the conditions of the
stud, the subject device is non-
irritating | Passes (Not a primary skin
irritant)
There was no erythema or
oedema noted on test site
after (1±0.1), (24±2),
(48±2) and (72±2) hours.
The primary Irritation Index
(PII) was "0". Also, no
mortality after 72 hours. The
gloves considered
negligible. | Similar |
| Biocompatibility | Dermal Sensitization- ISO
10993-10:2010 | Passes
Under the conditions of the
stud, the subject device is non-
sensitizing | Passes (Not a contact
sensitizer)
There was no positive
allergic reaction observed
during the challenge phase
(at 0, 24 hours and 48
hours) in animals treated
with the test material and
negative control. | Similar |
| Biocompatibility | Cytotoxicity - MEM Elution,
ISO 10993-5:2009 | Exhibit severe cytotoxicity
reactivity at 100% and 66%
extract concentration and no
cytotoxicity at 44%, 30%, 20%
and 15% extract concentration
under the condition of this test. | Exhibit severe cytotoxicity
reactivity at 100%, 50%,
and 25% extract
concentration.
No cytotoxicity reactivity at
12.5%, 6.25% and 3.125%
extract concentrations. | Similar |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON
ANALYSIS |
| | | PREDICATE | CURRENT | |
| | | BLUE | BLUE | |
| Biocompatibility | Acute Systemic Toxicity,
ISO 10993-11:2017 (E) | Passes
Under the conditions of the
study, the subject showed no
adverse biological reaction. | Passes (no adverse biological
reaction )
No mortality was observed
(72±2) hours | Same |
| Watertight (1000ml) | ASTM D6319-19 & ASTM
D5151 | Passes at AQL 1.5 | Passes at AQL 1.5 | Same |
| 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. | 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. | Same |
| | | These gloves were tested for
use with chemotherapy drugs
and Fentanyl Citrate per ASTM
D6978-05 (Reapproved 2019)
Standard Practice for
Assessment of Medical Gloves
to Permeation by
Chemotherapy Drugs. | These gloves were tested for
use with chemotherapy drugs
and Fentanyl Citrate per
ASTM D6978-05 (Reapproved
- Standard Practice for
Assessment of Medical Gloves
to Permeation by
Chemotherapy Drugs. | Same |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| | | BLUE | BLUE | |
| Chemotherapy Drugs Permeation Test ASTM D6978-05 (Reapproved 2019) | | | | |
| Chemotherapy Drug and
Concentration | ASTM D6978-05
(Reapproved 2019) | Minimum Breakthrough Detection Time (Minutes) | | |
| Azacitidine, 25mg/ml
(25,000 ppm) | | - | >240mins | Different |
| Bleomycin Sulphate
15mg/ml (15,000 ppm) | | - | >240mins | Different |
| Carboplatin 10mg/ml
(10,000 ppm) | | - | >240mins | Different |
| Carmustine (BCNU)
3.3mg/ml (3300 ppm) | | 18.32mins | 22.5mins | Similar |
| Cetuximab 2mg/ml (2000
ppm) | | - | >240mins | Different |
| Cisplatin 1mg/ml (1000
ppm) | | >240mins | >240mins | Same |
| Cyclophosphamide
(Cytoxan) 20mg/ml
(20,000 ppm) | | >240mins | >240mins | Same |
| Dacarbazine 10mg/ml
(10,000 ppm) | | >240mins | >240mins | Same |
| Docetaxel 10mg/ml (10,000
ppm) | | - | >240mins | Different |
| Doxorubicin HCl 2mg/ml
(2,000 ppm) | | >240mins | >240mins | Same |
| Ellence (Epirubicin) 2mg/ml
(2,000 ppm) | | - | >240mins | Different |
| Etoposide 20mg/ml (20,000
ppm) | | >240mins | >240mins | Same |
| | | | | |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON
ANALYSIS |
| | | PREDICATE
BLUE | CURRENT
BLUE | |
| Fluorouracil 50mg/ml
(50,000 ppm) | | >240mins | >240mins | Same |
| Gemcitabine 38mg/ml
(38,000 ppm) | | - | >240mins | Different |
| Ifosfamide 50mg/ml
(50,000 ppm) | | >240mins | >240mins | Same |
| Irinotecan 20mg/ml
(20,000 ppm) | | - | >240mins | Different |
| Methotrexate 25mg/ml
(25,000ppm) | | >240mins | >240mins | Same |
| Mitomycin C 0.5mg/ml (500
ppm) | | >240mins | >240mins | Same |
| Mitoxantrone 2mg/ml
(2,000 ppm) | | >240mins | >240mins | Same |
| Oxaliplatin 2mg/ml
(2,000ppm) | | - | >240mins | Different |
| Paclitaxel 6mg/ml (6,000
ppm) | | >240mins | >240mins | Same |
| Rituximab 10mg/ml
(10,000 ppm) | | - | >240mins | Different |
| Thio Tepa 10 mg/ml
(10,000 ppm) | | 57.3mins | 36.1mins | Different |
| Vincristine Sulfate 1mg/ml
1,000 ppm) | | >240mins | >240mins | Same |
| Vinorelbine 10mg/ml
(10,000 ppm) | | - | >240mins | Different |
| Warning | | Do Not Use with Camustine | Do Not Use with Camustine or
Thio Tepa. | Different |
| Fentanyl Citrate
100mcg/2ml | | >240mins | >240mins | Same |
| | | | | |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| | | BLUE | BLUE | |
| Size | Medical Glove Guidance
Manual - Labeling | Extra Small
Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large | Same |
| Single Use | Medical Glove Guidance
Manual – Labeling | Single use | Single use | Same |
8
9
10
11
12
13
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods.
However, the current glove is tested to many more chemotherapy drugs than the predicate and has passed the minimum penetration time of 240 minutes.
7.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical tests for this powder free nitrile patient examination gloves is summarized as per below.
14
| Test
| Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Before aging | After aging | Before aging | After aging | |||||
| Physical | ||||||||
| Properties | ASTM D412-16 | |||||||
| (Standard Test Method | ||||||||
| for Vulcanized Rubber | ||||||||
| and Thermoplastic | ||||||||
| Elastomers-Tension) | To evaluate the | |||||||
| tensile (tension) | ||||||||
| properties of glove. | Tensile | |||||||
| Strength | ||||||||
| Min 14 MPa | Min 14 MPa | 14.4 | 16.3 | Pass | ||||
| Ultimate | ||||||||
| Elongation | Min 500% | Min 400% | 506 | 402 | Pass |
| Test
| Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Dimension | ASTM D3767- | ||||
| 03(2020) Standard | |||||
| Practice for Rubber – | |||||
| Measurement of | |||||
| Dimensions | To measure the | ||||
| length, width, and | |||||
| thickness of glove | Length |
Width:
XS
S
M
L
XL
Thickness | Min 240mm
Min 240
Ave = 72 mm
Ave = 83 mm
Ave = 95 mm
Ave = 104 mm
Ave = 115 mm
Thickness
Finger – 0.08mm
Palm – 0.05mm | Pass
Pass
Pass
Pass
Pass
Pass
Pass |
| | | | Min 240mm
70 ± 10 mm
80 ± 10 mm
95± 10 mm
110 ± 10 mm
110
Finger – 0.05mm
Palm – 0.05mm | | |
15
| Test
| Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Water Tight | ASTM D 5151-19 | ||||
| Standard Test Method | |||||
| for Detection of Holes | |||||
| in Medical Gloves | To detect holes that | ||||
| leak water and | |||||
| thereby compromise | |||||
| the usefulness of the | |||||
| glove | Sample Size : 500 | ||||
| Inspection Level : GI | |||||
| AQL : 1.5 | |||||
| Acceptance No : 14 | This batch sampling is 500,001 | ||||
| and over. Hence according to | |||||
| single sampling plan GI, the | |||||
| sample to be drawn is under Code | |||||
| M equivalent to 500 pieces with | |||||
| accept 14 and reject 15. | |||||
| During the test, 12 pieces were | |||||
| found with leaks. Hence it falls | |||||
| within the acceptance criteria. | Pass |
| Test
| Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Residual | |||||
| Powder | ASTM D6124-06 | ||||
| (2017) Standard Test | |||||
| Method for Residual | |||||
| Powder on Medical | |||||
| Gloves | To determine the | ||||
| amount of residual | |||||
| powder and non- | |||||
| powder solids found | |||||
| on gloves | Less than 2 mg per glove | Sample size : 5 pcs | |||
| Requirement : |