(106 days)
Not Found
No
The document describes a standard medical examination glove and its performance against established ASTM standards. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No.
A therapeutic device is used to treat a disease or condition, whereas this device is a glove used by an examiner to prevent contamination.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic.
No
The device described is a physical patient examination glove, not a software-only medical device. The description focuses on material properties, physical dimensions, and performance against ASTM standards for gloves.
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 to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical properties and standards met by the glove (material, color, size, standards like ASTM D6319-10). This aligns with a medical device used for protection.
- Performance Studies and Key Metrics: The performance studies and key metrics relate to the glove's integrity, barrier properties (pinholes, powder residue), biocompatibility, and resistance to chemotherapy drugs. These are all relevant to a protective barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
In summary, the device is a medical device used for protection during patient examination, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
-
Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-6. I Sterile, Tested for Use with Chemotherapy Drugs
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove has been tested for use with specific chemotherapy drugs listed below. -
Device Name: Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-6.2 Sterile, Tested for Use with Chemotherapy Drugs
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove has been tested for use with specific chemotherapy drugs listed below.
Product codes (comma separated list FDA assigned to the subject device)
80 LZA, 80 LZC
Device Description
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs meet all of the requirements of ASTM D6319-10.
The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or orange color.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The gloves were tested in accordance with ASTM standards including:
- Dimensions: ASTM D6319-10. Meets Standard Requirements.
- Physical Properties: ASTM D6319-10. Meets Standard Requirements for Tensile Strength (>= 14 MPA before and after aging) and Elongation (> 500% before aging, > 400% after aging).
- Freedom from pinholes: ASTM D5151-11, ASTM D6319-10. Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5. Meets Standard Requirements.
- Powder Free Residue: ASTM D6124-11, ASTM D6319-10. Result generated values
§ 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
APR 0 8 2014 K133949
TOP CALIBRE SDN. BHD.
FDA 510(k), Premarket Notification: 510(k) Summary
Date : April 01, 2014
1.0 Submitter:
Top Calibre Sdn. Bhd. Lot 13726, Jalan Haji Salleh, Batu 5 1/4, Off Jalan Meru, 41050 Klang, Selangor, Malaysia
| Telephone No.: | +603 3291 0516 |
|---|---|
| Fax No.: | +603 3291 0542 |
2.0 Contact Person:
| Contact: | Ms Rosnita Maodin |
|---|---|
| Telephone No.: | +603 3291 0516 |
| Fax No.: | +603 3291 0542 |
3.0 Name of Device:
| Trade Name(s) | : Powder Free Nitrile Patient Examination Glove,
Blue Colored, Non-Sterile,
Tested for Use with Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove,
Orange Colored, Non-Sterile,
Tested for Use with Chemotherapy Drugs. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | : Powder-Free Nitrile Patient Examination Glove |
| Classification Name | : Patient Examination Glove |
| Regulation Number | : 21 CFR 880.6250 |
| Classification Number | : Class I |
| Product Code | : 80 LZA, 80 LZC |
4.0 Identification of the Legally Marketed Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs, Class I Patient Examination Gloves, Nitrile - 80 LZA, Specialty - 80 LZC, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Predicate Device: K091652, Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs-VBLU
Page 1 of 9 (Rev 3)
1
There are no different technological characteristics compared to the Predicate Device.
5.0 Description of Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs meet all of the requirements of ASTM D6319-10.
The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or orange color.
Intended Use of the Device: 6.0
- Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-6. I Sterile, Tested for Use with Chemotherapy Drugs
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 |
|---|---|
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (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 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug - Carmustine has extremely short permeation times of 15.1 minutes.
2
- Device Name: Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-6.2 Sterile, Tested for Use with Chemotherapy Drugs
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
|---|---|
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (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 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug - Carmustine has extremely short permeation times of 17.9 minutes.
7.0 Summary of the Technological Characteristics of the Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs posses the following technological characteristic (as compared to ASTM or equivalent standards):
3
| Characteristic | Standards
Requirements | Results Summary | Conclusions | | | | | | | | | |
|----------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|-----------------------------------|
| Dimensions | ASTM D6319-10 | Length ≥ 270mm
Palm Thickness ≥ 0.10mm
Finger Thickness ≥ 0.10mm
Width
X-Small 70-80mm
Small 80-90mm
Medium 90-100mm
Large 101-111mm
X-Large ≥ 111mm | Meets
Standard
Requirements | | | | | | | | | |
| Physical
Properties | ASTM D6319-10 | Before Aging After Aging Tensile Strength ≥ 14 MPA ≥ 14 MPA Elongation > 500% > 400% | | | | | | | | | | Meets
Standard
Requirements |
| | | | | | | | | | | | | |
| Freedom from
pinholes | ASTM D5151-11
ASTM D6319-10 | Tested in accordance with ASTM D5151 test
method. Pass quality level at G1 AQL 1.5 | Meets
Standard
Requirements | | | | | | | | | |
| Powder Free
Residue | ASTM D6124-11
ASTM D6319-10 | Result generated values ≤ 2 mg of residual powder
per glove | Meets
Standard
Requirements | | | | | | | | | |
| Biocompatibility | Dermal Sensitization
(as ISO 10993-
10:2010) | Not a contact skin sensitizer | Meets
Standard
Requirements | | | | | | | | | |
| | Primary Skin Irritation
Test (as ISO 10993-
10:2010) | Not a primary skin irritant | | | | | | | | | | |
| | | | | | | | | | | | | |
| Chemotherapy
Drugs
Permeation Test
Method | ASTM D6978-05 | Powder Free Nitrile Patient Examination Glove,
Blue Colored, Non-Sterile, Tested for Use with
Chemotherapy Drugs
Chemotherapy Drug Permeation
(Minimum Breakthrough Detection Time in Minutes) | Tested for Use
with
Chemotherapy
Drugs.
Carmustine
has extremely
short
permeation
times of 15.1
minutes. | | | | | | | | | |
| | | Carmustine (3.3 mg/ml) 15.1
Cisplatin (1.0 mg/ml) >240
Cyclophosphamide (20 mg/ml) >240
Cytarabine (100 mg/ml) >240
Dacarbazine (DTIC) (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 mg/ml) >240
Mitomycin C (0.5 mg/ml) >240
Mitoxantrone (2.0 mg/ml) >240
Paclitaxel (Taxol) (6.0 mg/ml) >240
Thiotepa (10.0 mg/ml) >240
Vincristine Sulfate (1.0 mg/ml) >240 | | | | | | | | | | |
4
| Characteristic | Standards
Requirements | Results Summary | Conclusions |
|----------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Chemotherapy
Drugs
Permeation Test
Method | ASTM D6978-05 | Powder Free Nitrile Patient Examination Glove,
Orange Colored, Non-Sterile, Tested for Use with
Chemotherapy Drugs | |
| | | Chemotherapy Drug Permeation
(Minimum Breakthrough Detection Time in Minutes) | Tested for Use
with |
| | | Carmustine (3.3 mg/ml) | 17.9 |
| | | Cisplatin (1.0 mg/ml) | >240 |
| | | Cyclophosphamide (20 mg/ml) | >240 |
| | | Cytarabine (100 mg/ml) | >240 |
| | | Dacarbazine (DTIC) (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 mg/ml) | >240 |
| | | Mitomycin C (0.5 mg/ml) | >240 |
| | | Mitoxantrone (2.0 mg/ml) | >240 |
| | | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| | | Thiotepa (10.0 mg/ml) | >240 |
| | | Vincristine Sulfate (1.0 mg/ml) | >240 |
| | | | Chemotherapy
Drugs.
Carmustine
has extremely
short
permeation
times of 17.9
minutes. |
8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs have been tested against the applicable ASTM standards listed above, and meet the requirements set forth in those standards.
There is no difference between the Proposed Devices and the Predicate Device with respect to performance standard and technological characteristics.
There is difference in colorant used in one of the Proposed Device (Orange), compared with Predicate Device (Blue). However, the difference does not affect the safety and effectiveness of the Proposed Device (Orange), as the Proposed Device (Orange) tested and passed Biocompatibility test, similar with Predicate Device.
The Proposed Devices were tested for 15 drugs, while the Predicate Device was tested for 12 drugs. The respective drug's permeation result is shown in Indication for Use of the Proposed Devices. The difference in labeling (with additional drugs tested, exceed ASTM D6978-05 requirements), and in Indications for Use do not affect the safety and effectiveness of the proposed devices.
5
9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
10.0 Conclusion
It can be concluded that the Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs are substantially equivalent to the predicate device identified in this 510(k) summary.
The Substantial Equivalent Comparison Table below outlines the similarity, and/or differences between the proposed devices and the predicate device for the substantial equivalent determination.
As such, this device is substantially equivalent to predicate device.
6
| BHD. |
|---|
| SDN. |
| CALIBRE |
| TOP |
Substantial Equivalent Comparison Table
.
| ics | Predicate Device | Proposed Device (Blue) | Predicate Device | Proposed Device (Orange) | |
|---|---|---|---|---|---|
| K091652 Nitrile Powder Free | |||||
| Examination Gloves (Blue) Tested | |||||
| for Use with Chemotherapy | |||||
| Drugs-VBLU | Powder Free Nitrile Patient | ||||
| Examination Glove, Blue | |||||
| Colored, Non-Sterile, Tested for | |||||
| Use with Chemotherapy Drugs | K091652 Nitrile Powder Free | ||||
| Examination Gloves (Blue) Tested | |||||
| for Use with Chemotherapy | |||||
| Drugs-VBLU | Powder Free Nitrile Patient | ||||
| Examination Glove, Orange | |||||
| Colored, Non-Sterile, Tested for | |||||
| Use with Chemotherapy Drugs | |||||
| cription/ | |||||
| umber | Patient Examination Glove/ | ||||
| 21 CFR Part 880.6250 | Substantial Equivalent | Patient Examination Glove/ | |||
| 21 CFR Part 880.6250 | Substantial Equivalent | ||||
| 80 LZA, 80 LZC | 80 LZA, 80 LZC | 80 LZA, 80 LZC | 80 LZA, 80 LZC | ||
| Intended for medical and dental | |||||
| purposes that is worn on the | |||||
| examiner's hand to prevent | |||||
| contamination between patient and | |||||
| examiner. | Substantial Equivalent | Intended for medical and dental | |||
| purposes that is worn on the | |||||
| examiner's hand to prevent | |||||
| contamination between patient and | |||||
| examiner. | Substantial Equivalent | ||||
| Characteristics | Predicate Device | ||||
| K091652 Nitrile Powder Free | |||||
| Examination Gloves (Blue) Tested for | |||||
| Use with Chemotherapy Drugs-VBLU | Proposed Device (Blue) | ||||
| Powder Free Nitrile Patient | |||||
| Examination Glove, Blue Colored, | |||||
| Non-Sterile, Tested for Use with | |||||
| Chemotherapy Drugs | Predicate Device | ||||
| K091652 Nitrile Powder Free | |||||
| Examination Gloves (Blue) Tested for | |||||
| Use with Chemotherapy Drugs-VBLU | Proposed Device (Orange) | ||||
| Powder Free Nitrile Patient | |||||
| Examination Glove, Orange Colored, | |||||
| Non-Sterile, Tested for Use with | |||||
| Chemotherapy Drugs | |||||
| Indications for Use | The Nitrile Examination Glove (Tested | ||||
| for Use with Chemotherapy Drugs) is a | |||||
| disposable device intended for medical | |||||
| and dental-purposes that is worn on the | |||||
| examiner's hand to prevent | |||||
| contamination between patient and | |||||
| examiner. The list of chemotherapy | |||||
| drugs tested (with breakthrough times) | |||||
| are as follows:- | A patient examination glove is a | ||||
| disposable device intended for | |||||
| medical purposes that is worn on the | |||||
| examiner's hand to prevent | |||||
| contamination between patient and | |||||
| examiner. | |||||
| This glove has been tested for use | |||||
| with specific chemotherapy drugs | |||||
| listed below. | The Nitrile Examination Glove | ||||
| (Tested for Use with Chemotherapy | |||||
| Drugs) is a disposable device intended | |||||
| for medical and dental purposes that is | |||||
| worn on the examiner's hand to | |||||
| prevent contamination between patient | |||||
| and examiner. The list of | |||||
| chemotherapy drugs tested (with | |||||
| breakthrough times) are as follows:- | A patient examination glove is a | ||||
| disposable device intended for | |||||
| medical purposes that is worn on the | |||||
| examiner's hand to prevent | |||||
| contamination between patient and | |||||
| examiner. | |||||
| This glove has been tested for use | |||||
| with specific chemotherapy drugs | |||||
| listed below. | |||||
| Chemotherapy Drug Permeation | |||||
| (Minimum Breakthrough Detection | |||||
| Time in Minutes) | Chemotherapy Drugs | ||||
| Breakthrough Time (Minutes) | Chemotherapy Drug Permeation | ||||
| (Minimum Breakthrough Detection | |||||
| Time in Minutes) | |||||
| Carmustine (3.3 mg/ml) | Carmustine | 6.60 | |||
| Cisplatin (1.0 mg/ml) | Cisplatin | >240 | |||
| Cyclophosphamide | |||||
| (20mg/ml) | Cyclophosphamide (Cytoxan) | >240 | |||
| Cytarabine (100 mg/ml) | Dacarbazine | >240 | |||
| Dacarbazine (DTIC) | |||||
| (10.0 mg/ml) | Doxorubicin Hydrochloride | >240 | |||
| Doxorubicin Hydrochloride | |||||
| (2.0 mg/ml) | Etoposide | >240 | |||
| Etoposide (20.0 mg/ml) | Fluorouracil | >240 | |||
| Fluorouracil (50.0 mg/ml) | Methotrexate | >240 | |||
| Ifosfamide (50.0 mg/ml) | Mitomycin C | >240 | |||
| Methotrexate (25 mg/ml) | Paclitaxel | >240 | |||
| Mitomycin C (0.5 mg/ml) | Thiotepa | 14.83 | |||
| Mitoxantrone (2.0 mg/ml) | Vincristine Sulfate | >240 | |||
| Paclitaxel (Taxol) (6.0 mg/ml) | Warning: Do not use with | ||||
| Carmustine and Thiotepa. | |||||
| Thiotepa (10.0 mg/ml) | |||||
| Vincristine Sulfate (1.0 mg/ml) | |||||
| Please note that the following drug |
- Carmustine has extremely short
permeation times of 17.9 minutes. | | | | |
Page 7 of 9 (Rev 3)
. . . .
.
7
Page 8 of 9 (Rev 3)
:
8
| BHD. |
|---|
| SDN. |
| CALIBRE |
| ГОР |
| Characteristics | Predicate Device
K091652 Nitrile Powder Free
Examination Gloves (Blue) Tested
for Use with Chemotherapy
Drugs-VBLU | Proposed Device (Blue)
Powder Free Nitrile Patient
Examination Glove, Blue
Colored, Non-Sterile, Tested for
Use with Chemotherapy Drugs
Substantial Equivalent | Predicate Device
K091652 Nitrile Powder Free
Examination Gloves (Blue) Tested
for Use with Chemotherapy
Drugs-VBLU | Proposed Device (Orange)
Powder Free Nitrile Patient
Examination Glove, Orange
Colored, Non-Sterile, Tested for
Use with Chemotherapy Drugs
Substantial Equivalent |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Nitrile | Substantial Equivalent | Nitrile | Substantial Equivalent |
| Color | Blue | Substantial Equivalent | Blue | Orange |
| Design | Ambidextrous, in different sizes
per ASTM D6319 dimension
requirement. | Substantial Equivalent | Ambidextrous, in different sizes
per ASTM D6319 dimension
requirement. | Substantial Equivalent |
| Performance
I. Sterility | Not Applicable (Non-Sterile) | Substantial Equivalent | Not Applicable (Non-Sterile) | Substantial Equivalent |
| II. Freedom from
holes | Passes at AQL 1.5 | Passes at AQL 1.5 (Substantial
Equivalent) | Passes at AQL 1.5 | Passes at AQL 1.5 (Substantial
Equivalent) |
| III. Dimension | Meets ASTM D6319 | Meets ASTM D6319 (Substantial
Equivalent) | Meets ASTM D6319 | Meets ASTM D6319 (Substantial
Equivalent) |
| IV. Physical
Properties | Meets ASTM D6319 | Meets ASTM D6319 (Substantial
Equivalent) | Meets ASTM D6319 | Meets ASTM D6319 (Substantial
Equivalent) |
| V. Powder Free
Residue | Meets ≤ 2 mg/glove | Meets ≤ 2 mg/glove (Substantial
Equivalent) | Meets ≤ 2 mg/glove | Meets ≤ 2 mg/glove (Substantial
Equivalent) |
| Single Use | Yes | Substantial Equivalent | Yes | Substantial Equivalent |
| Biocompatibility
Test | Passes
i. Primary Skin Irritation Test
ii. Dermal Sensitization Test | Not an irritant
Not a contact sensitizer | Passes
i. Primary Skin Irritation Test
ii. Dermal Sensitization Test | Not an irritant
Not a contact sensitizer |
| Packaging | Packed in Dispenser Boxes | Substantial Equivalent | Packed in Dispenser Boxes | Substantial Equivalent |
| Labeling Claim | Tested For Use with
Chemotherapy Drugs | Substantial Equivalent | Tested For Use with
Chemotherapy Drugs | Substantial Equivalent |
Page 9 of 9 (Rev 3)
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
April 8, 2014
Top Calibre Sdn. Bhd. Ms. Rosnita Maodin Quality Assurance Manager Lot 13726, Jalan Haji Salleh, Batu 5 ¼ , Off Jalan Meru Klang, Selangor MALAYSIA 41050
Re: K133949
Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-sterile, Tested for Use with Chemotherapy Drugs
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: March 3, 2014 Received: March 6, 2014
Dear Ms. Maodin:
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. 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.
10
Page 2 - Ms. Maodin
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 t CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
Sincerely yours,
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known):
Device Name:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breaktbrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 |
| Cytarabine (100 mg/ml) | > 240 |
| Dacarbazine (DTIC) (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 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | > 240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug - Carmustine has extremely short permeation times of 15.1 minutes.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (2) CFR 801 Subpan C) x
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Elizabeth F. Claverie -S 2014.04.07 23:45:16 -04'00'
Page 1 of _
12
Indications for Use
510(k) Number (if known):
Device Name:
Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 |
| Cytarabine (100 mg/ml) | > 240 |
| Dacarbazine (DTIC) (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 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | > 240 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that the following drug . Carmustine has extremely short permeation times of 17,9 minutes.
× AND/OR Prescription Use Over-The-Counter Use (Part 2) CFR 801 Subpart D) (2) CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Elizabeth F. Claverie -S 2014.04.07 23:46:05 -04'00'
Page I of .