Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a surgical glove and its physical properties and performance against standards, with no mention of AI or ML.

Therapeutic

No.
The device is described as a "surgeon's glove" intended for protection from contamination, not for treating a disease or condition.

Diagnostic

No
The provided text describes a surgical glove intended for protection during surgery, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made of synthetic rubber, intended to be worn by operating room personnel. It is a tangible hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as a "disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination." This describes a barrier device used during surgery, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the material (synthetic rubber), manufacturing process, and physical features of a surgical glove.
Performance Studies: The performance studies mentioned (Biocompatibility, Physical Characteristics, Chemotherapy Drug Permeation) are relevant to the safety and performance of a surgical glove as a barrier and protective device, not to the diagnostic capabilities of an IVD.
Key Metrics: The key metric mentioned is "Minimum Breakthrough Detection Time for chemotherapy drugs," which relates to the barrier function of the glove, not a diagnostic measurement.

IVD devices are used to test samples like blood, urine, or tissue to detect diseases, conditions, or infections. This device is a physical barrier used during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM and the most go res world of Medical Gloves to Permeation by Chemotherapy Drugs:

Blenoxane (15 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Busulfan (6 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Carmustine (BCNU) (3.3 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute 0.37
Cisplastin, (1.0 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Cytarabine (100 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Cyclophosphamide (20 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Dacarbazine (10 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Doxorubicin HCl (2.0 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Ellence (25 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Etoposide (Toposar) (20 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Fludarabine (25 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Fluorouracil (50 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Idarubicin (1 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Ifosfamide (50 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Mechlorethamine HCl (1 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Melphalan (5 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Methotrexate (25 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Mitoxantrone (2 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Mitomycin C (0.5 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Paclitaxel (Taxol) (6.0 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Paraplatin (10 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Rituximab (10 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Thiotepa (10 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute 0.44
Trisenox (0.1 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240
Vincristine sulfate (1 mg/ml) Min Breakthrough Detection Time, 0.01 µg/cm²/minute >240

Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.37 minute; Thiotepa (10 mg/ml) has a minimum breakthrough time of 0.44 minute.

Product codes (comma separated list FDA assigned to the subject device)

KGO, LZC

Device Description

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is a synthetic rubber latex. This Sterile Polyisoprene Powder-Free Surgical Glove is manufactured using exact same material used in the currently cleared device, Esteem SMT glove (K093300) that has been legally marketed by Cardinal Health. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.

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

Operating room 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 tests were conducted for determination of substantial equivalence.
Biocompatibility:

Primary Skin Irritation: Tested with ISO 10993-10. Results: Gloves are non-irritating.
Guinea Pig Maximization: Tested with ISO 10993-10. Results: Gloves do not display any potential for sensitization.

Physical Characteristics:

Dimensions: Tested with ASTM D3577. Results: Meet requirements.
Physical Properties: Tested with ASTM D3577. Results: Meet requirements for rubber surgical gloves.
Freedom from Holes: Tested with 21 CFR 800.20 & ASTM D3577. Results: Tested in accordance with ASTM D5151 with acceptable results.
Powder Residual: Tested with ASTM D3577 using ASTM standard D6124. Results: Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized graphic above the company name. The graphic is made up of curved lines that resemble a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

JUN - 8 2511

STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES

(A summary of safety and effectiveness information in accordance with the requirements of 21 CFR 807.92)

| Applicant: | Cardinal Health
1430 Waukegan Road
McGaw Park, IL 60085 |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 1423537 |
| Regulatory Affairs
Contact: | Tatyana Bogdan, RAC |
| Telephone: | 847-887-2325 |
| Fax: | 847-887-2717 |
| E-mail: | tatyana.bogdan-curvin@cardinalhealth.com |
| Summary Prepared: | May 13, 2011 |
| Trade Name: | Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with
Chemotherapy Drugs |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Panel: | General and Plastic Surgery |
| Regulation: | 21 CFR 878.4460 |
| Product Code(s): | KGO |
| Legally marketed
device(s) to which
equivalence is claimed: | 1. Esteem SMT Sterile Polyisoprene Powder-Free Surgical Gloves ( 510(k) K093300, product code KGO)
2. Duraprene Sterile Neoprene Powder-Free Surgical Gloves (510(k) K013302, product code KGO) |
| Reason for 510(k)
Submission: | Addition of new indications for use: Tested for Use with Chemotherapy Drugs |
| Device Description: | The proposed device is a disposable device. It is not made with natural rubber
latex. Instead, it is formulated from polyisoprene, which is a synthetic rubber
latex. This Sterile Polyisoprene Powder-Free Surgical Glove is manufactured
using exact same material used in the currently cleared device, Esteem SMT
glove (K093300) that has been legally marketed by Cardinal Health. The glove
is manufactured using molds that feature anti-slip finish, independent thumb,
and tapered mechanically locking cuffs to help reduce cuff roll down. It is
offered powder-free and sterile. |

1

Intended Use:

This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM m and the most go res world of Medical Gloves to Permeation by Chemotherapy Drugs:

| | Chemotherapy µg/cm²/minute |
|-----|----------------------- | 1. | Blenoxane (15 mg/ml) | 2. | Busulfan (6 mg/ml) | 3. | Carmustine (BCNU) (3.3 mg/ml) | 4. | Cisplastin, (1.0 mg/ml) | 5. | Cytarabine (100 mg/ml) | 6. | Cyclophosphamide (20 mg/ml) | 7. | Dacarbazine (10 mg/ml) | 8. | Doxorubicin HCl (2.0 mg/ml) | 9. | Ellence (25 mg/ml) | 10. | Etoposide (Toposar) (20 mg/ml) | 11. | Fludarabine (25 mg/ml) | 12. | Fluorouracil (50 mg/ml) | 13. | Idarubicin (1 mg/ml) | 14. | Ifosfamide (50 mg/ml) | 15. | Mechlorethamine HCl (1 mg/ml) | 16. | Melphalan (5 mg/ml) | 17. | Methotrexate (25 mg/ml) | 18. | Mitoxantrone (2 mg/ml) | 19. | Mitomycin C (0.5 mg/ml) | 20. | Paclitaxel (Taxol) (6.0 mg/ml) | 21. | Paraplatin (10 mg/ml) | 22. | Rituximab (10 mg/ml) | 23. | Thiotepa (10 mg/ml) | 24. | Trisenox (0.1 mg/ml) | 25. | Vincristine sulfate (1 mg/ml) Drug and Concentration | Min Breakthrough Detection Time, 0.01
--------------|--------------------------------------------------------|
| >240 |
| >240 |
| 0.37 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| 0.44 |
| >240 |
| >240 |

Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.37 minute; Thiotepa (10 mg/ml) has a minimum breakthrough time of 0.44 minute.

2

KIIO2112

Summary of the technological characteristics of the device compared to the predicate device
Characteristic	New Device
(K110272)	Predicate
Sterile Polyisoprene Powder
Free Surgical Glove
(K093300)	Predicate
Sterile Neoprene Powder-
Free Surgical Glove
(K013302)
Material
Composition	Polyisoprene Synthetic
Rubber Latex	Polyisoprene Synthetic
Rubber Latex	Synthetic Neoprene Polymer
coated with Nitrile
Design	Single Use
Sterile
Powder-free
Hand Specific
Independent Thumb
Beaded Cuff
Lubricated	Single Use
Sterile
Powder-free
Hand Specific
Independent Thumb
Beaded Cuff
Lubricated	Single Use
Sterile
Powder-free
Hand Specific
Independent Thumb
Beaded Cuff
Lubricated
Intended Use	Powder-Free Surgeon's
Glove	Powder-Free Surgeon's
Glove	Powder-Free Surgeon's
Glove
Indications for Use	Tested for Use with
Chemotherapy Drugs	Not Tested	Tested for Use with
Chemotherapy Drugs
Dimensions &
Physical Properties	Meets ASTM D3577	Meets ASTM D3577	Meets ASTM D3577
Freedom from
Holes	AQL meets 21CFR 800.20 &
ASTM D3577 requirements	AQL meets 21CFR 800.20 &
ASTM D3577 requirements	AQL meets 21CFR 800.20 &
ASTM D3577 requirements
Powder Residual	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
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*
Performance Test Summary-New Device
Characteristic		Standard/Test/FDA Guidance	Results Summary
Biocompatibility:
Primary Skin Irritation		ISO 10993-10	Gloves are non-irritating.
Guinea Pig Maximization		ISO 10993-10	Gloves do not display any potential for
sensitization.
Physical Characteristics:
Dimensions		ASTM D3577	Meet requirements
Physical Properties		ASTM D3577	Meet requirements for rubber surgical gloves
Freedom from Holes		21 CFR 800.20 & ASTM D3577	Tested in accordance with ASTM D5151 with
acceptable results
Powder Residual		ASTM D3577 tested using
ASTM standard D6124	Gloves meet powder level requirements for
"Powder-Free" designation per ASTM D3577.
Results generated values 240
2.	Busulfan (6 mg/ml)	>240
3.	Carmustine (BCNU) (3.3 mg/ml)	0.37
4.	Cisplastin, (1.0 mg/ml)	>240
5.	Cytarabine (100 mg/ml)	>240
6.	Cyclophosphamide (20 mg/ml)	>240
7.	Dacarbazine (10 mg/ml)	>240
8.	Doxorubicin HCl (2.0 mg/ml)	>240
9.	Ellence (25 mg/ml)	>240

(Continued on next page)

X Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Clavine-Williams

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110272

Page / of 2

5

7

Continued from previous page)
	Chemotherapy Drug and
Concentration	Minimum Breakthrough Detection Time
in Minutes, 0.01 µg/cm²/minute
10.	Etoposide (Toposar) (20 mg/ml)	>240
11.	Fludarabine (25 mg/ml)	>240
12.	Fluorouracil (50 mg/ml)	>240
13.	Idarubicin (1 mg/ml)	>240
14.	Ifosfamide (50 mg/ml)	>240
15.	Mechlorethamine HCl (1 mg/ml)	>240
16.	Melphalan (5 mg/ml)	>240
17.	Methotrexate (25 mg/ml)	>240
18.	Mitoxantrone (2 mg/ml)	>240
19.	Mitomycin C (0.5 mg/ml)	>240
20.	Paclitaxel (Taxol) (6.0 mg/ml)	>240
21.	Paraplatin (10 mg/ml)	>240
22.	Rituximab (10 mg/ml)	>240
23.	Thiotepa (10 mg/ml)	0.44
24.	Trisenox (0.1 mg/ml)	>240
25.	Vincristine sulfate (1 mg/ml)	>240

Please note that the following drugs have extremely low permeation time of less than 30 minutes:

Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.37 minute.

Thiotepa (10 mg/ml) has a minimum breakthrough time of 0.44 minute.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Clausing-Williams

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices l

510(k) Number: K110272

Page 2 of 2

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