(288 days)
Not Found
No
The device is a physical examination glove and the summary describes standard material properties and performance testing, with no mention of AI or ML.
No
The device is a medical glove, designed to prevent contamination between patient and examiner, and does not provide therapy or treatment.
No
Explanation: The device described is a patient examination glove, designed for protection and contamination prevention, not for diagnosing medical conditions.
No
The device is a physical examination glove made of nitrile synthetic rubber, clearly described as a hardware product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for "medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description reinforces the barrier function and mentions testing for protection against certain substances, which is related to the barrier's integrity and effectiveness, not a diagnostic test.
- Lack of Diagnostic Function: An IVD is a device intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such examination or provide diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the glove (tensile strength, elongation, freedom from holes, powder content) and its barrier properties against certain substances (chemotherapy drugs, simulated gastric acid, fentanyl citrate). These are all related to the glove's function as a protective barrier, not a diagnostic tool.
In summary, the device is a medical glove intended for protection and contamination prevention, not for performing diagnostic tests on patient specimens.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
Device Description
The Powder Free Nitrile Examination Gloves, Blue Color, Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between patient and examiner. The gloves are ambidextrous, i.e. can be worn on right hand or left hand.
The gloves are manufactured from nitrile synthetic rubber. Inner surface of gloves undergo 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 gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate per ASTM D6978-05(2019).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical purpose
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)
Non-Clinical Performance Data:
Biocompatibility Testing:
- ISO 10993-10: Biological Evaluation of Medical Devices, Part 10 - Irritation Testing: Pass (Not a primary skin irritant)
- ISO 10993-10: Biological Evaluation of Medical Devices, Part 10 - Sensitization Testing: Pass (Not a primary skin sensitizer)
- ISO 10993-5: Biological Evaluation of Medical Devices, Part 5 - In Vitro Cytotoxicity Testing: Failed (Exhibit cytotoxicity reactivity)
- ISO 10993-11: Biological Evaluation of Medical Devices, Part 11 - Systemic Toxicity Testing: Pass (Not toxic)
Performance Test Data:
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06, Standard Tested Method for Residual Powder on medical Gloves
Physical Dimensions:
- Length: All sizes (X-Small to XX-Large) met the minimum length criteria as per ASTM D6319-19.
- Width: All sizes met the specified width ranges as per ASTM D6319-19.
- Palm Thickness: All sizes met the minimum thickness criteria as per ASTM D6319-19.
- Finger Thickness: All sizes met the minimum thickness criteria as per ASTM D6319-19.
Physical Properties:
- Tensile Strength (MPa): Met minimum criteria both before and after aging (14 MPa min).
- Ultimate Elongation (%): Met minimum criteria both before and after aging (500% min before, 400% min after).
Freedom from Holes:
- Met ASTM D5151-06 Standard, G-1, AQL 2.5 criteria.
Powder Content:
- Met ASTM D6124-06 criteria ( 240 min
- Carmustine (BCNU): 58.3 min (Not recommended for use due to low permeation time)
- Cisplatin: > 240 min
- Cyclophosphamide (Cytoxan): > 240 min
- Dacarbazine: > 240 min
- Docetaxel: > 240 min
- Doxorubicin HCI: > 240 min
- Etoposide: > 240 min
- Fluorouracil: > 240 min
- Ifosfamide: > 240 min
- Methotrexate: > 240 min
- Mitomycin C: > 240 min
- Paclitaxel: > 240 min
- ThioTepa: 119 min (Not recommended for use due to low permeation time)
- Vincristine Sulfate: > 240 min
- Simulated Gastric Acid Fluid: > 240 min
- Fentanyl Citrate Injection: > 240 min
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 18, 2022
Pt. Maja Agung Latexindo % Jeni Chuason Official Correspondent Shamrock Marketing Co., Inc. 5445 Daniels Street Chino, California 91710
Re: K212408
Trade/Device Name: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, 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, OPJ, ODO Dated: April 20, 2022 Received: April 25, 2022
Dear Jeni Chuason:
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 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,
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) K212408
Device Name
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate).
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate.
| Chemotherapy Drug and Permeation | |
|---|---|
| The following chemicals have been tested with these gloves: | |
| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes |
| Carboplatin (Paraplatin), 10 mg/ml (10,000ppm) | > 240 min. |
| Carmustine (BCNU), 3.3 mg/ml (3,300ppm) | 58.3 min (Not recommended for use) |
| Cisplatin, 1.0 mg/ml (1,000ppm) | > 240 min |
| Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000 ppm) | > 240 min |
| Dacarbazine, 10.0mg/ml (10,000ppm) | > 240 min |
| Docetaxel, 10mg/ml (10,000ppm) | > 240 min |
| Doxorubicin HCI, 2.0mg/ml (2,000ppm) | > 240 min |
| Etoposide, 20.0mg/ml (20,000ppm) | > 240 min |
| Fluorouracil, 50.0mg/ml (50,000ppm) | > 240 min |
| Ifosfamide, 50 mg/ml (50,000 ppm) | > 240 min |
| Methotrexate, 25mg/ml (25,000 ppm) | > 240 min |
| Mitomycin C, 0.5 mg/ml (500 ppm) | > 240 min |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) | > 240 min |
| ThioTepa, 10.0mg/ml (10,000ppm) | 119 min (Not recommended for use) |
| Vincristine Sulfate, 1 mg/ml (1,000 ppm) | > 240 min |
| Simulated Gastric Acid | > 240 min |
| Fentanyl Citrate Injection 100.0 mg/2ml | > 240 min |
WARNING: Do not use with Carmustine (BCNU) 3.3 mg/ml and Thiotepa (10mg/ml).
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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Image /page/4/Picture/0 description: The image shows the logo for PT. MAJAAGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized "Ma" in red on the left, with blue horizontal lines behind it. To the right of the "Ma" is the company name in green, with the words "Manufacturer of Latex Gloves" in smaller black font below.
510(k) Summary K212408
1) Submitter
| Name of applicant: | Sivaprakash.S |
|---|---|
| Address: | PT. MAJA AGUNG LATEXINDO |
| Jl. Utama No. 98, Pujimulyo, Sunggal 20352 Deli Serdang | |
| North Sumatera - Indonesia | |
| Phone No.: | 62-61-8459170 |
| Fax No.: | 62-61-8459180 |
| Email: | mal@shamrock.co.id |
| Contact person in USA: | Jeni Chuason |
| Phone No.: | (909) 591-8855 |
| Fax No: | (909) 591-8878 |
| Email: | jenit@smcgloves.com |
Summary preparation Date: July 19, 2021 Type of submission: Traditional
2) Device Information:
Device Name /
| Device Name / Trade Name: | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate) |
|---|---|
| Classification Name: | Patient Exam Glove, Medical Gloves with Chemotherapy / Simulated Gastric Acid / Fentanyl Citrate Labeling Claims |
| Classification: | Class I, Non-Sterile |
| Classification panel: | General Hospital |
| Regulation Number: | 21 CFR 880.6250 |
| Common Name: | Patient Examination Glove, Specialty |
| Product Code: | LZA, LZC, OPJ, QDO |
3) Identification of the Legally Marketed Devices That Equivalency is Claimed:
Primary Predicate: Device name: EMG Blue Nitrile Examination Gloves Powder free with tested for use with Chemotherapy Drugs Company: ECO Medi Glove Sdn. Bhd 510(k): K171339 Regulatory Class I Product Code: LZA, LZC
4) Device Description:
The Powder Free Nitrile Examination Gloves, Blue Color, Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate are non-sterile, single use, disposable gloves intended for
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Image /page/5/Picture/0 description: The image contains a logo for PT. MAJAAGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized red graphic on the left, with the company name in green text on the right. The words "Manufacturer of Latex Gloves" are printed in a smaller font below the company name.
medical purposes to be worn on the hands of examiners to prevent contamination between patient and examiner. The gloves are ambidextrous, i.e. can be worn on right hand or left hand.
The gloves are manufactured from nitrile synthetic rubber. Inner surface of gloves undergo 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 gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate per ASTM D6978-05(2019).
| 4.1. Dimension and Thickness of the Gloves | ||||||
|---|---|---|---|---|---|---|
| Dimension | Size | |||||
| Overall Length (mm) min. | XS | S | M | L | XL | XXL |
| 220 | 220 | 230 | 230 | 230 | 230 | |
| Palm Width (mm) min. | $70 \pm 10$ | $80 \pm 10$ | $95 \pm 10$ | $110 \pm 10$ | $120 \pm 10$ | $130 \pm 10$ |
| Thickness (mm) min. | ||||||
| Cuff | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 |
| Palm | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 |
| Fingertip | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 |
Gloves Specification
4.2. Physical Properties and Freedom of Pinholes
| Measurement | Before Aging | After Aging at
70°C for 168 hours |
|-----------------------------|---------------------------------|--------------------------------------|
| Tensile Strength (mpa) | 14 min. | 14 min. |
| Ultimate Elongation (%) | 500 min. | 400 min. |
| Freedom from pinholes Level | AQL 2.5
Inspection Level G-1 | AQL 2.5
Inspection Level G-1 |
5) Indications for Use:
Powder Free Nitrile Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Test Results follows:
| Drugs Name | Concentration Tested | Breakthrough Detection
Time
(Minutes) |
|--------------------------|-----------------------|---------------------------------------------|
| Carboplatin (Paraplatin) | 10 mg/ml (10,000 ppm) | > 240 min |
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Image /page/6/Picture/0 description: The image shows the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo consists of two parts: a stylized "Ma" in red and blue stripes on the left, and the company name in green on the right. The words "Manufacturer of Latex Gloves" are written in a smaller font below the company name.
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 58.3 min |
|---|---|---|
| Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 min |
| Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) | > 240 min |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 min |
| Docetaxel | 10 mg/ml (10,000 ppm) | > 240 min |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | > 240 min |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 min |
| Fluorouracil | 50 mg/ml (50,000 ppm) | > 240 min |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 min |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 min |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 min |
| Paclitaxel | 6 mg/ml (6,000 ppm) | > 240 min |
| ThioTepa | 10 mg/ml (10,000 ppm) | 119 min |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 min |
| Simulated Gastric Acid Fluid | > 240 min | |
| Fentanyl Citrate Injection | 100mcg/2mL | >240 min |
Please note that the following drugs that have low permeation time are:
Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) 58.3 min.
ThioTepa, 10 mg/ml (10,000 ppm) 119.0 min
Caution: Testing showed an average of breakthrough time 58.3-67.3 for Carmustine and 119 for ThioTepa
6) Comparison of the Technological Characteristics of the Device:
| Device
Characteristic | Predicate Device | Proposed Device | Comparison
Analysis |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | Eco Medi Glove Sdn, Bhd | PT. MAJA AGUNG
LATEXINDO | N/A |
| Product code | LZA, LZC | LZA, LZC, OPJ, QDO | N/A |
| Trade Name | EMG Blue Nitrile Patient
Examination Gloves Powder
Free Tested for Use with
Chemotherapy Drugs | Powder Free Nitrile
Examination Gloves (Tested for
Use with Chemotherapy Drugs,
Simulated Gastric Acid, and
Fentanyl Citrate) | N/A |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| 510(K) | K171339 | K212408 | Same |
| Intended use | A powder free patient | A patient examination glove is a | Similar |
| | examination glove is a
disposable device intended for
medical purpose that is worn on
examiner's hand to prevent
contamination between patient
and examiner. | disposable device intended for
medical purpose that is worn on
examiner's hand to prevent
contamination between patient
and examiner.
These gloves were tested for use
with Chemotherapy Drugs,
Simulated Gastric Acid, and
Fentanyl Citrate as per ASTM
D6978-05(2019) Standard
Practice for Assessment of
Medical Gloves to Permeation
by Chemotherapy Drugs. | |
| Rx or OTC | Over the counter | Over the counter | Same |
| Materials | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Single use | Single use | Same |
| Contact Duration | N/A | Limited ≤ 24 hours | Different |
| Dimensions | Meets ASTM D6319-10
Size: Medium
Palm Width: 98 mm
Length: 247 mm
Finger Thickness: 0.08 mm
Palm Thickness: 0.05 mm | Complies with:
ASTM D6319-10
Size: XS, S, M, L, XL, XXL
Palm Width: 95 ± 10 (size M)
Length: min 230 mm
Finger Thickness: 0.13 mm
Palm Thickness: min 0.12 mm | Similar |
| Physical Properties | Tensile strength (Mpa):
Before Aging: 25.45 Mpa
After Accelerated aging: 26.33 Mpa
Ultimate Elongation(%):
Before Aging: 600%
After Aging: 550%
Meets ASTM D6319-10 | Tensile strength (Mpa):
Before Aging: min 14 Mpa
After Accelerated aging: 14 Mpa
Ultimate Elongation(%):
Before Aging: min 500%
After Aging: min 400%
Meets ASTM D6319-10 | Similar |
| Freedom from
pinholes | AQL 2.5
Meets ASTM D5151-06 | AQL 2.5
Meets ASTM D5151-06 | Same |
| Residual Powder | Complies with ASTM D6124-06
Average (size M):
0.17 mg/glove | Complies with ASTM D6124-06
Average (size M):
0.35mg/glove | Similar |
| Biocompatibility:
ISO 10993-10:
Skin Irritation Test | Not a skin irritant | Not a skin irritant | Same |
| Skin Sensitizer
ISO 10993-11: | Not a skin sensitizer | Not a skin sensitizer | |
| Systemic Toxicity | Not available | Not Toxic | Different |
| Tested
Chemotherapy
Drugs and
breakthrough
detection time in
minutes | | | |
| | Carboplatin (Paraplatin)
10mg/ml (10,000 ppm)
240 min | Carboplatin (Paraplatin)
10mg/ml (10,000 ppm)
240 min | Same |
| | Carmustine (BCNU) 3.3 mg/ml
(3300 ppm)
24 mins | Carmustine (BCNU) 3.3 mg/ml
(3300 ppm)
58.3 mins | Similar |
| | Cisplatin 1mg/ml (1000 ppm)
240 min | Cisplatin 1mg/ml (1000 ppm)
240 min | Same |
| | Cyclophosphamide (Cytoxan)
20mg/ml (20000 ppm)
240 min | Cyclophosphamide (Cytoxan)
20mg/ml (20000 ppm)
240 min | Same |
| | Dacarbazine 10mg/ml (10000 ppm) >240 min | Dacarbazine 10mg/ml (10000 ppm) >240 min | Same |
| | | Docetaxel 10mg/ml (10000 ppm) >240 min | Different |
| | Doxorubicin HCl 2mg/ml (2000 ppm) >240 min | Doxorubicin HCl 2mg/ml (2000 ppm) >240 min | Same |
| | Etoposide 20mg/ml (2000 ppm)
240 min | Etoposide 20mg/ml (2000 ppm)
240 min | Same |
| | Fluorouracil 50mg/ml (50000 ppm) >240 min | Fluorouracil 50mg/ml (50000 ppm) >240 min | Same |
| | Ifosfamide 50mg/ml (50000 ppm) >240 min | Ifosfamide 50mg/ml (50000 ppm) >240 min | Same |
| | Methotrexate 25mg/ml (25000 ppm) >240 min | Methotrexate 25mg/ml (25000 ppm) >240 min | Same |
| | Mitomycin C 0.5mg/ml (500 ppm) >240 min | Mitomycin C 0.5mg/ml (500 ppm) >240 min | Same |
| | Mitoxantrone 2mg/ml
240 min | | Different |
| | Paclitaxel 6mg/ml (6000 ppm)
240 min | Paclitaxel 6mg/ml (6000 ppm)
240 min | Same |
| | ThioTepa 10mg/ml (10000 ppm)
56.9 mins | ThioTepa 10mg/ml (10000 ppm)
119 mins | Similar |
| | Vincristine Sulfate 1mg/ml
(1000 ppm)
240 min | Vincristine Sulfate 1mg/ml
(1000 ppm)
240 min | Same |
| Simulated
Gastric
Acid | | Simulated Gastric Acid Fluid
240 min | Different |
| Fentanyl Testing | | Fentanyl Citrate Injection
100mcg/2mL
240 min | Different |
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Image /page/7/Picture/0 description: The image contains the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized "Ma" in red and blue on the left. To the right of the logo is the company name in green, with "Manufacturer of Latex Gloves" in a smaller font below.
8
Image /page/8/Picture/0 description: The image is a company logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized "Ma" in red on the left, with blue horizontal lines behind it. To the right of the "Ma" is the company name in green, with "PT. MAJA AGUNG" on top and "LATEXINDO" below it. Underneath the company name is the text "Manufacturer of Latex Gloves" in a smaller font.
9
Image /page/9/Picture/0 description: The image shows the logo for PT. MAJAAGUNG LATEXINDO, a manufacturer of latex gloves. The logo consists of two parts: a stylized red "Ma" on a blue striped background, and the company name in green, with "PT. MAJAAGUNG" on top and "LATEXINDO" below. Underneath the company name, it says "Manufacturer of Latex Gloves" in a smaller, gray font.
Summary of the technological characteristics of the proposed device in comparison to the predicate device.
Based on the comparison of technological characteristics between proposed device and the predicate device, the devices were found to be similar in terms of indications for use, dimension, physical properties, freedom from pinholes, and residual powder and met with ASTM D5151-06 and D6319-19 standard. Both proposed and predicate devices also were tested for use with chemotherapy drugs per ASTM D6978-05 standard, but the proposed device also added fentanyl and simulated gastric acid testing that made the difference. Lastly, both performed biocompatibility testing and found with the similar result to be nonirritant, non-sensitizer, nor toxic.
7) Substantial Equivalent Based on Assessment of Non-Clinical Performance Data.
Summary of Non-Clinical Testing
a. Biocompatibility Testing
| Name of test / citation | Purpose | Acceptance
Criteria | Results |
|-----------------------------------------------------------------------|----------------------------------|------------------------|----------------------------------------------|
| ISO 10993-10: Biological
Evaluation of Medical Devices,
Part 10 | Irritation Testing | Pass/Fail | Pass
Not a primary skin
irritant |
| ISO 10993-10: Biological
Evaluation of Medical Devices,
Part 10 | Sensitization Testing | Pass/Fail | Pass
Not a primary skin
sensitizer |
| ISO 10993-5: Biological
Evaluation of Medical Devices,
Part 5 | In Vitro Cytotoxicity
Testing | Pass/Fail | Failed
Exhibit cytotoxicity
reactivity |
| ISO 10993-11: Biological
Evaluation of Medical Devices,
Part 11 | Systemic Toxicity
Testing | Pass/Fail | Pass
Not toxic |
Table below summarize the biocompatibility testing result
b. Performance Test Data - Summary of Non-Clinical Testing
The test results demonstrated that the proposed device met the performance criteria as specified utilizing the following test method, standards, and specification:
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application ●
- ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06, Standard Tested Method for Residual Powder on medical Gloves ●
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Image /page/10/Picture/0 description: The image is a logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo features the company's name in green, with the words "PT. MAJA AGUNG" on top of "LATEXINDO". Below the name is the text "Manufacturer of Latex Gloves" in a smaller font. To the left of the company name is a red and blue graphic.
Physical Dimensions
| Purpose
Dimension | Test Method
ASTM D6319-19 | Size | (mm) | Test Result
(mm) | Acceptance
Criteria (Y/N) |
|----------------------|------------------------------|-------------|----------|---------------------|------------------------------|
| Length | | X-Small | 220 min | 240 - 245 | Y |
| | | Small | 220 min | 240-245 | Y |
| | | Medium | 230 | 240 - 245 | Y |
| | | Large | 230 | 240-243 | Y |
| | | Extra-Large | 230 | 240-243 | Y |
| | | XX-Large | 230 | 240 - 242 | Y |
| Width | | X-Small | 70 ± 10 | 77-79 | Y |
| | | Small | 80 ± 10 | 84-86 | Y |
| | | Medium | 95 ± 10 | 95-97 | Y |
| | | Large | 110 ± 10 | 104-106 | Y |
| | | Extra-Large | 120 ± 10 | 111-115 | Y |
| | | XX-Large | 130 ± 10 | 120-123 | Y |
| Palm Thickness | | X-Small | 0.05 min | 0.12 | Y |
| | | Small | 0.05 min | 0.12 | Y |
| | | Medium | 0.05 min | 0.12 | Y |
| | | Large | 0.05 min | 0.12 | Y |
| | | Extra-Large | 0.05 min | 0.12 | Y |
| | | XX-Large | 0.05 min | 0.12 | Y |
| Finger
Thickness | | X-Small | 0.08 min | 0.13 | Y |
| | | Small | 0.08 min | 0.13 | Y |
| | | Medium | 0.05 min | 0.13 | Y |
| | | Large | 0.05 min | 0.13 | Y |
| | | Extra-Large | 0.05 min | 0.13 | Y |
| | | XX-Large | 0.05 min | 0.13 | Y |
Physical Properties
| Purpose | Test Method | Test Result | | Acceptance
Criteria
(Y/N) | |
|------------------------|------------------------|-------------------------------------|-------------------|-------------------------------------|---|
| Physical
Properties | ASTM D6319-19 Standard | | | | |
| | Before Aging | After Aging at
70°C, 166 ± 2 hrs | Before Aging | After Aging at
70°C, 166 ± 2 hrs | |
| Tensile
Strength | 14 MPa min | 14 MPa min | 17.55 – 20.90 MPa | 15.00 – 19.95 MPa | Y |
| Ultimate
Elongation | 500% min | 400% min | 750 – 830% | 625 – 770% | Y |
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Image /page/11/Picture/0 description: The image contains a logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo consists of two parts: a graphic on the left and text on the right. The graphic features a stylized "Ma" in red, overlaid on a blue striped background with a red border. The text reads "PT. MAJA AGUNG" in bold, dark green letters, followed by "LATEXINDO" in a similar font and color. Below this, the text "Manufacturer of Latex Gloves" is written in a smaller, less bold font.
Freedom from Holes
| Purpose | Test Method | Test Result | Acceptance
Criteria (Y/N) |
|-----------------------|-----------------------------------------|-----------------------------------------------------------------------------|------------------------------|
| Freedom from
Holes | ASTM D5151-06 Standard,
G-1, AQL 2.5 | XS/XXL – 0/160
S/M/XL – 1/250
L – 2/250
Passed Standard Acceptance | Y |
Powder Content
| Purpose | Test Method | Test Result | Acceptance
Criteria (Y/N) |
|----------|----------------|-----------------------------------|------------------------------|
| Residual | ASTM D6124-06, | X-Small: 0.34 mg/glove (Average) | Y |
| Powder | 240 min | Y |
| Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | ASTM
D6978-05 | 58.3 min | N |
| Cisplatin, 1.0 mg/ml (1,000 ppm) | | > 240 min | Y |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm) | | > 240 min | Y |
| Dacarbazine, 10.0 mg/ml (10,000 ppm) | | > 240 min | Y |
| Docetaxel, 10 mg/ml (10,000 ppm) | | > 240 min | Y |
| Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) | | > 240 min | Y |
| Etoposide, 20.0 mg/ml (20,000 ppm) | | > 240 min | Y |
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Image /page/12/Picture/0 description: The image shows the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo consists of two parts: a stylized "Ma" in red and blue on the left, and the company name in green on the right. Below the company name is the text "Manufacturer of Latex Gloves" in a smaller font size.
| Fluorouracil, 50.0 mg/ml (50,000 ppm) | > 240 min | Y |
|---|---|---|
| Ifosfamide, 50 mg/ml (50,000 ppm) | > 240 min | Y |
| Methotrexate, 25 mg/ml (25,000 ppm) | > 240 min | Y |
| Mitomycin C, 0.5 mg/ml (500 ppm) | > 240 min | Y |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) | > 240 min | Y |
| ThioTepa, 10.0 mg/ml (10,000 ppm) | 119 min | N |
| Vincristine Sulfate, 1 mg/ml (1,000 ppm) | > 240 min | Y |
| Simulated Gastric Acid Fluid | >240 min | Y |
| Fentanyl Citrate Injection 100mcg/2mL | >240 min | Y |
8) Summary of Clinical Testing
Not applicable - Clinical data is not needed for gloves or most devices cleared by the 510(k) process.
9) 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 device.