(102 days)
No
The device description and performance studies focus on the physical properties, barrier function, and chemical resistance of a surgical glove, with no mention of AI or ML technology.
No.
The device is described as a barrier for protection against cross-contamination, not for treating a disease or condition.
No
This device is a surgical glove intended as a barrier for protection against cross-contamination, not for diagnosing medical conditions.
No
The device description clearly states it is a physical glove made of synthetic rubber, and the performance studies focus on physical properties and material resistance, not software functionality.
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 barrier for protection against cross-contamination between healthcare personnel and patients. This is a physical barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and materials of the glove, designed for protection and ease of use.
- Performance Studies: The performance studies evaluate physical properties, watertightness, biocompatibility, and resistance to chemicals (chemotherapy drugs and fentanyl). These are all related to the glove's barrier function and safety, not its ability to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
IVD devices are used to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. This surgical glove does not perform any such diagnostic function.
N/A
Intended Use / Indications for Use
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration Average Breakthrough Detection Time (Minutes) |
|---|---|
| *Carmustine (BCNU) (3.3 mg/ml) | 24.0 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| *ThioTepa (10.0 mg/ml) | 23.1 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 minutes and Thiotepa: 23.1. Do not use with Carmustine and Thiotepa
| Fentanyl Resistance | Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100mcg/2mL) | No breakthrough up to 240 minutes |
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC, OPJ, QDO
Device Description
Powder Free Polyisoprene Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance meets all the requirements of ASTM standard D3577, ASTM D6978-05 and FDA 21 CFR 878.4460.
The powder free polyisoprene surgical glove is manufactured from 100% synthetic polyisoprene latex. 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 hand specific. The physical properties of qlove, i.e., tensile strength meets ASTM standard D3577. Device is intended for single use.
The powder free polyisoprene surgical glove, sterile is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9. This glove comes in natural color and powder free.
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
healthcare personnel
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 testing was performed as summarized below. No clinical study was included.
Physical Properties
- Test Method: ASTM D412 (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. 17MPa, Ultimate elongation Min. 650%, Stress at 500% Elongation Max. 7.0MPa
- After Aging: Tensile strength Min. 12MPa, Ultimate elongation Min. 490%, Stress at 500% Elongation N/A
- Results: Pass (for all criteria before and after aging)
Dimension
- Test Method: ASTM D3767 (Standard Practice for Rubber - Measurement of Dimensions)
- Purpose: To measure the length, width and thickness of glove
- Acceptance Criteria:
- Length: 5½ - Min. 245 mm; 6.0 - Min. 265 mm; 6½ - Min. 265 mm; 7.0 - Min. 265 mm; 7½ - Min. 265 mm; 8.0 - Min. 265 mm; 8½ - Min. 265 mm; 9.0 - Min. 265 mm
- Width: 5½ - 70 ± 6 mm; 6.0 - 76 ± 6 mm; 6½ - 83 ± 6 mm; 7.0 - 89 ± 6 mm; 7½ - 95 ± 6 mm; 8.0 - 102 ± 6 mm; 8½ - 108 ± 6 mm; 9.0 - 114 ± 6 mm
- Thickness: Finger - Min. 0.10 mm; Palm - Min. 0.10 mm; Cuff - Min. 0.10 mm
- Results: Pass (for all specified dimensions)
Watertight
- Test Method: ASTM D5151 (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: 125 pcs, Inspection level: GI, AQL:0.65, Acceptance No. 2, Found 1
- Results: Pass
Residual Powder
- Test Method: ASTM D6124 (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: Have a powder residue limit of 2.0 mg per glove
- Results: Pass
Biocompatibility
- Primary Skin Irritation:
- Standard: ISO 10993-10 (E) & Consumer Product Safety Commission Title 16, Chapter II, Part 1500
- Purpose: To assess the potential of glove to produce dermal irritation
- Acceptance Criteria: Not a primary skin irritation
- Results: Pass
- Dermal Sensitization:
- Standard: ISO 10993-10 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3 (c) (4)
- Purpose: To assess the potential of glove to cause a delayed hypersensitivity (Type IV) immunological response
- Acceptance Criteria: Not a contact sensitizer
- Results: Pass
- Acute Systemic Toxicity:
- Standard: ISO 10993-11 (E)
- Purpose: To determine the acute systemic toxicity potential of glove
- Acceptance Criteria: No biological reactivity shown
- Results: Pass
- Material Mediated Pyrogenicity:
- Standard: ISO 10993-11 (E)
- Purpose: To determine any pyrogenic response induced by the glove
- Acceptance Criteria: No increase of temperature
- Results: Pass
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.
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
October 22, 2022
WRP Asia Pacific SDN. BHD. % Michael Scaglione U.S. Agent WRP USA Inc 3700 Massillon Road Suite 340 Uniontown, Ohio 44685
Re: K222058
Trade/Device Name: Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I. reserved Product Code: KGO, LZC, OPJ, QDO Dated: July 6, 2022 Received: July 12, 2022
Dear Michael Scaglione:
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. 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
2
Indications for Use
510(k) Number (if known) K222058
Device Name
POLYISOPRENE SURGICAL GLOVE, POWDER FREE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL RESISTANCE
Indications for Use (Describe)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration Average Breakthrough Detection Time (Minutes) |
|---|---|
| *Carmustine (BCNU) (3.3 mg/ml) | 24.0 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| *ThioTepa (10.0 mg/ml) | 23.1 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 minutes and Thiotepa: 23.1. Do not use with Carmustine and Thiotepa
| Fentanyl Resistance | Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100mcg/2mL) | No breakthrough up to 240 minutes |
Type of Use (Select one or both, as applicable)
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ❌ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
K222058
1.0 Submitter:
| Name | : Saravanan Ramasamy |
|---|---|
| Address | : WRP Asia Pacific Sdn. Bhd. |
| Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak | |
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No. | : +60 3 8706 1486 |
| Fax No. | : +60 3 8706 1557 |
| Date of Summary | |
| Prepared | : 10/20/2022 |
2.0 Identification of the subject device:
| Trade Name | : Polyisoprene Surgical Glove, Powder Free, Sterile,
Tested for Use with Chemotherapy Drugs and Fentany
Resistance |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------|
| Common Name | : Surgical Gloves |
| Classification Name | : Surgeon's Gloves |
| Device Classification | : I |
| Regulation Number | : 21 CFR 878.4460 |
| Product Code | : KGO, LZC, OPJ, QDO |
3.0 Predicate Device:
| Predicate | |
|---|---|
| Manufacturer | WRP Asia Pacific Sdn. Bhd. |
| Device name | Powder Free Polymer Coated Polyisoprene |
| Surgical Glove, Sterile | |
| 510(k) Number | K032942 |
| Regulatory Class | I |
| Product Code | KGO |
4.0 Reference Device:
| Reference | |
|---|---|
| Manufacturer | WRP Asia Pacific Sdn. Bhd. |
| Device name | Powder Free Nitrile Surgical Glove, Sterile, Tested |
| for Use with Chemotherapy Drugs | |
| 510(k) Number | K203030 |
| Regulatory Class | I |
| Product Code | KGO, LZC |
5
Description of The Device: 5.0
Powder Free Polyisoprene Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance meets all the requirements of ASTM standard D3577, ASTM D6978-05 and FDA 21 CFR 878.4460.
The powder free polyisoprene surgical glove is manufactured from 100% synthetic polyisoprene latex. 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 hand specific. The physical properties of qlove, i.e., tensile strength meets ASTM standard D3577. Device is intended for single use.
The powder free polyisoprene surgical glove, sterile is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9. This glove comes in natural color and powder free.
6.0 Indication for use:
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug Permeation
| The following chemicals have been tested with these gloves. | ||
|---|---|---|
| Chemotherapy Drug | Concentration | Breakthrough |
| Detection Time | ||
| (Minutes) | ||
| *Carmustine (BCNU) | 3.3 mg/ml | 24.0 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Ifosfamide | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
6
| Mitoxantrone | 2.0 mg/ml | > 240 |
|---|---|---|
| Paclitaxel | 6.0 mg/ml | > 240 |
| *ThioTepa | 10.0 mg/ml | 23.1 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 and ThioTepa: 23.1. Do not use with Carmustine and Thiotepa.
| Fentanyl Resistant | Concentration | Breakthrough Detection
Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240
minutes |
7.0 Summary of the Technological Characteristics of the Device:
The Powder Free Polyisoprene Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs and Fentanyl Resistance are summarized with the following technological characteristics compared to ASTM D3577 or equivalent standards as shown in Table 1.
7
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | CURRENT | |||
| 510(k) Number | - | K032942 | K203030 | K222058 | - |
| Manufacturer(s) | - | WRP Asia Pacific Sdn. Bhd. | WRP Asia Pacific Sdn. Bhd. | WRP Asia Pacific Sdn. Bhd. | Same |
| Material | ASTM D3577 | Polyisoprene Rubber | Nitrile | Polyisoprene Rubber | Different |
| Color | - | Cream | Natural | Natural White | Different |
| Texture | - | Micro roughened | Bisque Finish | Bisque Finish | Different |
| Physical Properties | ASTM D3577 | Meets | Meets | Meets | Same |
| Before Aging | |||||
| Tensile Strength: | |||||
| Ultimate | |||||
| Elongation: | |||||
| Stress at 500% | |||||
| Elongation: | |||||
| After Aging | |||||
| Tensile Strength: | |||||
| Ultimate | |||||
| Elongation: | |||||
| Stress at 500% | |||||
| Elongation: | Min. 17MPa | ||||
| Min. 650% | |||||
| Max. 7.0MPa | |||||
| Meets | |||||
| Min. 12MPa | |||||
| Min. 490% | |||||
| N/A | Meets | Min. 17MPa | |||
| Min. 650% | |||||
| Max. 7.0MPa | |||||
| Meets | |||||
| Min. 12MPa | |||||
| Min. 490% | |||||
| N/A | Same |
8
| | STANDARD
S | DEVICE PERFORMANCE | | | | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| CHARACTERISTICS | | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS | |
| 510(k) Number | - | K032942 | K203030 | K222058 | | |
| Thickness: | ASTM D3577 | Meets | Meets | Meets | Same | |
| - Finger
- Palm
- Cuff | | Min. 0.10 mm
Min. 0.10 mm
Min. 0.10 mm | Min. 0.10 mm | Min. 0.10 mm
Min. 0.10 mm
Min. 0.10 mm | | |
| Dimension, | ASTM D3577 | Meets | Meets | Meets | Same | |
| Length | | 5½: Min. 245mm | 5½: Min. 245 mm | 5½: Min. 245 mm | | |
| | | 6.0: Min. 265 mm | 6.0: Min. 265 mm | 6.0: Min. 265 mm | | |
| | | 6½: Min. 265 mm | 6½: Min. 265 mm | 6½: Min. 265 mm | | |
| | | 7.0: Min. 265 mm | 7.0: Min. 265 mm | 7.0: Min. 265 mm | | |
| | | 7½: Min. 265 mm | 7½: Min. 265 mm | 7½: Min. 265 mm | | |
| | | 8.0: Min. 265 mm | 8.0: Min. 265 mm | 8.0: Min. 265 mm | | |
| | | 8½: Min. 265 mm | 8½: Min. 265 mm | 8½: Min. 265 mm | | |
| | | 9.0: Min. 265 mm | 9.0: Min. 265 mm | 9.0: Min. 265 mm | | |
| Dimension, Width | ASTM D3577 | Meets | Meets | Meets | Same | |
| | | 5½: 70 ± 6 mm | 5½: 70 ± 6 mm | 5½: 70 ± 6 mm | | |
| | | 6.0: 76 ± 6 mm | 6.0: 76 ± 6 mm | 6.0: 76 ± 6 mm | | |
| | | 6½: 83 ± 6 mm | 6½: 83 ± 6 mm | 6½: 83 ± 6 mm | | |
| | | 7.0: 89 ± 6 mm | 7.0: 89 ± 6 mm | 7.0: 89 ± 6 mm | | |
| | | 7½: 95 ± 6 mm | 7½: 95 ± 6 mm | 7½: 95 ± 6 mm | | |
| | | 8.0: 102 ± 6 mm | 8.0: 102 ± 6 mm | 8.0: 102 ± 6 mm | | |
| | | 8½: 108 ± 6 mm | 8½: 108 ± 6 mm | 8½: 108 ± 6 mm | | |
| | | 9.0: 114 ± 6 mm | 9.0: 114 ± 6 mm | 9.0: 114 ± 6 mm | | |
| | STANDARDS | DEVICE PERFORMANCE | | | | |
| CHARACTERISTICS | | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS | |
| 510(k) Number | | K032942 | K203030 | K222058 | | |
| Powder Free | ASTM D6124 | Meets
requirements of
≤2.0 mg/glove
for Powder-Free
designation per
ASTM D3577 | Meets
requirements of
≤2.0 mg/glove
for Powder-Free
designation per
ASTM D3577 | Meets
requirements of
≤2.0 mg/glove
for Powder-Free
designation per
ASTM D3577 | Same | |
| Biocompatibility | Primary Skin
Irritation -
ISO 10993-
10 (E) &
Consumer
Product
Safety
Commission
Title 16,
Chapter II,
Part 1500 | Passes (Not a
primary skin
irritant). | Passes (Not a
primary skin
irritant). | Passes (Not a
primary skin
irritant). | Similar | |
| | Dermal
Sensitization - ISO
10993-10
(E) &
Consumer
Product
Safety
Commission,
Title 16,
Chapter II,
Part 1500.3
(c) (4) | Passes (Not a
contact sensitizer). | Passes (Not a
contact
sensitizer). | Passes (Not a
contact
sensitizer). | Similar | |
| CHARACTERISTICS | STANDARD
S | PREDICATE | DEVICE PERFORMANCE | REFERENCE | CURRENT | COMPARISON ANALYSIS |
| 510(k) Number | - | K032942 | | K203030 | K222058 | - |
| | Acute
Systemic
Toxicity, ISO
10993-11
(E) | N/a | | It is concluded
that the product
did not induce
any systemic
toxicity | It is concluded
that the product
did not induce
any systemic
toxicity | Different |
| | Material
Mediated
Pyrogenicity,
ISO 10993-
11 (E) | N/a | | It is concluded
that the product
is considered to
be non-pyrogenic | It is concluded
that the product
is considered to
be non-pyrogenic | Different |
| Watertight
(1000ml) | ASTM D5151 | Meets 21 CFR
800.20 and
ASTM D3577 when
tested in
accordance with
ASTM D5151
Inspection Level 1,
AQL 1.5. | | Meets 21 CFR
800.20 and ASTM
D3577 when
tested in
accordance with
ASTM D5151
Inspection Level
I, AQL 0.65 | Meets 21 CFR
800.20 and ASTM
D3577 when
tested in
accordance with
ASTM D5151
Inspection Level
I, AQL 0.65 | Similar (AQL was subsequently
lowered after FDA cleared the
predicate) |
| Intended use /
Indications for Use | - | A powder free,
polymer coated
polyisoprene
surgical glove,
sterile, is made of
synthetic rubber
latex and intended
to be worn on the
hand of healthcare
personnel | | A powder-free
sterile surgeon's
glove is a
disposable device
made of synthetic
rubber intended
to be worn on the
hands of
healthcare
personnel as a | A powder-free
sterile surgeon's
glove is a
disposable device
made of synthetic
rubber intended
to be worn on the
hands of
healthcare
personnel as a | Same with additional characteristics. |
| CHARACTERISTICS | STANDARDS | PREDICATE | DEVICE PERFORMANCE
REFERENCE | CURRENT | COMPARISON ANALYSIS | |
| 510(k) Number | - | K032942 | K203030 | K222058 | - | |
| | | operating room
personnel and
similar personnel
to prevent
contamination
between the
healthcare or
similar personnel
and the patient's
body, fluids,
waste, or
environment. | barrier for
protection against
cross-
contamination
between the
healthcare
personnel and
patient.
These gloves
were tested for
use with
chemotherapy
drugs in
accordance with
ASTM D6978-05
Standard Practice
for Assessment of
Medical Gloves to
Permeation by
Chemotherapy
Drugs. | barrier for
protection against
cross-
contamination
between the
healthcare
personnel and
patient.
These gloves
were tested for
use with
Chemotherapy
Drugs and
Fentanyl Citrate
as per ASTM
D6978 Standard
Practice for
Assessment of
Medical Gloves to
Permeation by
Chemotherapy
Drugs | | |
| CHARACTERISTICS | STANDARD
S | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS | |
| 510(k) Number | - | K032942 | K203030 | K222058 | - | |
| Size | Medical
Glove
Guidance
Manual -
Labeling | 5½
6.0
6½
7.0
7½
8.0
8½
9.0 | 5½
6.0
6½
7.0
7½
8.0
8½
9.0 | 5½
6.0
6½
7.0
7½
8.0
8½
9.0 | Same | |
| Single Use | Medical
Glove
Guidance
Manual -
Labeling | Single use | Single use | Single use | Same | |
| Sterility Status | Medical
Glove
Guidance
Manual -
Labeling | Sterile | Sterile | Sterile | Same | |
| Sterility Method | ISO 11137-1
ISO 11137-2 | Gamma Radiation | Gamma Radiation | Gamma Radiation | Same | |
| | | | | | | |
| CHARACTERISTICS | STANDARD
S | DEVICE PERFORMANCE | | | COMPARISON ANALYSIS | |
| | | PREDICATE | REFERENCE | CURRENT | | |
| 510(k) Number | | K032942 | K203030 | K222058 | - | |
| Chemotherapy
Drug Permeation
Test | ASTM
D6978-05 | | | | Minimum Breakthrough Detection Time (Minutes) | |
| * Carmustine (BCNU)
(3.3 mg/ml) | | N/A | 27.3 | 24.0 | Different | |
| Cisplatin (1.0 mg/ml) | | N/A | > 240 | > 240 | Different | |
| Cyclophosphamide
(Cytoxan) (20.0
mg/ml) | | N/A | > 240 | > 240 | Different | |
| Dacarbazine (10.0
mg/ml) | | N/A | > 240 | > 240 | Different | |
| Doxorubicin
Hydrochloride (2.0
mg/ml) | | N/A | > 240 | > 240 | Different | |
| Etoposide (20.0
mg/ml) | | N/A | > 240 | > 240 | Different | |
| Fluorouracil (50.0
mg/ml) | | N/A | > 240 | > 240 | Different | |
| Ifosfamide (50.0
mg/ml) | | N/A | > 240 | > 240 | Different | |
| Methotrexate (25.0
mg/ml) | | N/A | > 240 | > 240 | Different | |
| Mitomycin C (0.5
mg/ml) | | N/A | > 240 | > 240 | Different | |
| Mitoxantrone (2.0
mg/ml) | | N/A | > 240 | > 240 | Different | |
| Paclitaxel (6.0
mg/ml) | | N/A | > 240 | > 240 | Different | |
| CHARACTERISTICS | STANDARD S | DEVICE PERFORMANCE | | | COMPARISON ANALYSIS | |
| | | PREDICATE | REFERENCE | CURRENT | | |
| 510(k) Number | - | K032942 | K203030 | K222058 | - | |
| * ThioTepa (10.0 mg/ml) | | N/A | 26.9 | 23.1 | Different | |
| Vincristine Sulfate (1.0 mg/ml) | | N/A | > 240 | > 240 | Different | |
| Warning Statement | | N/A | CAUTION: Testing showed an average breakthrough time of 27.3 minutes for Carmustine and an average breakthrough time of 26.9 minutes for ThioTepa | WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 minutes and Thiotepa: 23.1. Do not use with Carmustine and Thiotepa | Different | |
| Fentanyl Resistant | ASTM D6978-05 | N/A | N/A | > 240 | Different | |
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There are no significant differences between the devices and are identical in terms of intended use, material, color and size. Both devices meet the applicable requirements for surgical gloves regarding physical properties, freedom from holes, and powder residues.
Unlike the predicate, the current device has been tested for Acute Systemic Toxicity and for use with Chemotherapy Drugs and Fentanyl Citrate in accordance to ASTM D6978-05, which is a recognized attribute claim in FDA's Glove Guidance Manual and in other cleared surgical gloves, such as K203030 which is included are a reference.
8.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical test for this Powder Free Polyisoprene Surgical Glove, Sterile is summarized as per below.
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| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | | Results | | |
|------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------|--------------------------------------|----------------------|---------------------|
| | | | Before
Aging | After
Aging | Before
Aging | After
Aging | |
| Physical
Properties | ASTM D412
(Standard Test
Method for
Vulcanized Rubber
and Thermoplastic
Elastomers -
Tension) | To evaluate the
tensile (tension)
properties of glove | Tensile
strength
Ultimate
elongation
Stress at
500%
Elongation | Min.
17MPa
Min.
650%
Max.
7.0MPa | Min.
12MPa
Min.
490%
N/A | Pass
Pass
Pass | Pass
Pass
N/A |
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| Test
| Method | Standard | Purpose of Testing | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimension | ASTM D3767 | |||
| (Standard Practice | ||||
| for Rubber - | ||||
| Measurement of | ||||
| Dimensions) | To measure the | |||
| length, width and | ||||
| thickness of glove | Length 5½ - Min. 245 mm | Pass | ||
| 6.0 - Min. 265 mm | Pass | |||
| 6½ - Min. 265 mm | Pass | |||
| 7.0 - Min. 265 mm | Pass | |||
| 7½ - Min. 265 mm | Pass | |||
| 8.0 - Min. 265 mm | Pass | |||
| 8½ - Min. 265 mm | Pass | |||
| 9.0 - Min. 265 mm | Pass | |||
| Width 5½ - 70 ± 6 mm | Pass | |||
| 6.0 - 76 ± 6 mm | Pass | |||
| 6½ - 83 ± 6 mm | Pass | |||
| 7.0 - 89 ± 6 mm | Pass | |||
| 7½ - 95 ± 6 mm | Pass | |||
| 8.0 - 102 ± 6 mm | Pass | |||
| 8½ - 108 ± 6 mm | Pass | |||
| 9.0 - 114 ± 6 mm | Pass | |||
| Test | ||||
| Method | Standard | Purpose of Testing | Acceptance Criteria | Results |
| Dimension | ASTM D3767 | |||
| (Standard Practice | ||||
| for Rubber - | ||||
| Measurement of | ||||
| Dimensions) | To measure the | |||
| length, width and | ||||
| thickness of glove | Thickness Finger - Min. 0.10 mm | Pass | ||
| Palm - Min. 0.10 mm | Pass | |||
| Cuff - Min. 0.10 mm | Pass |
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| Test
| Method | Standard | Purpose of Testing | Acceptance Criteria | Results |
|---|---|---|---|---|
| Watertight | ASTM D5151 | |||
| (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: 125 pcs | |||
| Inspection level: GI | ||||
| AQL:0.65, Acceptance No. | ||||
| 2, Found 1 | Pass |
| Test
| Method | Standard | Purpose of Testing | Acceptance Criteria | Results |
|---|---|---|---|---|
| Residual | ||||
| Powder | ASTM D6124 | |||
| (Standard Test | ||||
| Method for Residual | ||||
| Powder on Medical | ||||
| Gloves) | To determine the | |||
| amount of residual | ||||
| powder and non- | ||||
| powder solids found | ||||
| on gloves | Have a powder residue limit | |||
| of 2.0 mg per glove | Pass |
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| Test Method | Standard | Purpose of
Testing | Acceptance Criteria | Results |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------|
| Biocompatibility | Primary Skin
Irritation - ISO
10993-10 (E) &
Consumer Product
Safety Commission
Title 16, Chapter
II, Part 1500 | To assess the
potential of glove to
produce dermal
irritation | Not a primary skin
irritation | Pass |
| Biocompatibility | Dermal
Sensitization- ISO
10993-10 (E) &
Consumer Product
Safety
Commission, Title
16, Chapter II, Part
1500.3 (c) (4) | To assess the
potential of glove to
cause a delayed
hypersensitivity
(Type IV)
immunological
response | Not a contact sensitizer | Pass |
| Biocompatibility | Acute Systemic
Toxicity, ISO
10993-11 (E) | To determine the
acute systemic
toxicity potential of
glove | No biological reactivity
shown | Pass |
| Biocompatibility | Material Mediated
Pyrogenicity, ISO
10993-11 (E) | To determine any
pyrogenic response
induced by the
glove | No increase of
temperature | Pass |
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8.0 Summary of Clinical Testing:
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance is as safe, as effective, and performs as well as or better than the legally marketed predicate device K032942.